What is an N95 respirator?

What is an N95 respirator 

The NIOSH respiratory protection approval regulation (42 CFR 84) defines the term “N95” to refer to a filter class, not 

a respirator. However, many filtering facepiece respirators have an N95 class filter and many people refer to them, 

and have come to know them, as N95 respirators. A filtering facepiece respirator that filters out at least 95% of 

airborne particles during “worse case” testing using a “most-penetrating” sized particle is given a 95 rating. 1 There are 

nine classes of NIOSH-approved particulate filtering respirators available at this time. 95% is the minimal level of 

filtration that will be approved by NIOSH. The N, R and P designations refer to the filter's oil resistance as described 

in the table below. 

Filter Class 

Description 

N95, N99, N100 Filters at least 95%, 99%, 99.97% of airborne particles. Not resistant to oil. 

R95, R99, R100 Filters at least 95%, 99%, 99.97% of airborne particles. Somewhat resistant to oil. 

P95, P99, P100 Filters at least 95%, 99%, 99.97% of airborne particles. Strongly resistant to oil. 

All NIOSH-approved filtering facepiece respirators are marked with the manufacturer’s name, the part number (P/N), 

the protection provided by the filter (e.g., N95, P100), and “NIOSH.” Some filtering facepiece respirators approved by 

NIOSH may have the NIOSH approval number (TC-84A-xxxx) as an additional identification marking. This 

information is printed either on the face, exhalation valve (if one exists), or head straps (see Figure 1). The lot number 

or date of manufacture may appear on the respirator or may be located on the packaging. View a listing of all NIOSHapproved 

particulate filtering facepiece respirators. NIOSH also maintains a separate database of all NIOSHapproved 

respirators, inclusive of all respirator types on the Certified Equipment List. 

If a particulate filtering facepiece respirator does not have these markings as identified above and does not 

appear on one of these lists, it has not been certified by NIOSH for occupational use. 

Figure 1 

1 

Reference: Rengasamy,S.,W.P.King, B.C.Eimer and R.E. Shaffer.(2008). Filtration performance of NIOSHapproved 

N95 and P100 filtering facepiece respirators against 4 to 30 nanometer-size nanoparticles. Journal of 

Occupational and Environmental Hygiene 5(9):556-564.

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Healthcare-Related FAQs 

• Is a surgical mask an N95 respirator 

• What is a surgical N95 respirator 

• Can the products with an exhalation valve be used in healthcare 

• Do N95 respirators come in different sizes 

• How do I know what size I need 

• Do N95 respirators come in different styles 

• Why do some N95 respirators have an exhalation valve on the front 

• Does moisture build up in respirators 

• What are the differences among these products 

• How long can you wear the same N95 respirator 

• Can it be used from Operating Room (OR) case to OR case or from patient to patient 

• Is cross contamination a concern if I wear the same N95 from patient room to patient room 

• Can I take a N95 respirator off in between patients or Operating Room cases 

• How should I store my N95 in between patient encounters, in a healthcare setting 

• Can I infect myself from the droplets that accumulate on the outside of the respirator 

• Do I need special training to wear an N95 or do I put it on and wear it like a surgical mask 

• Can we use an N95 that has not been cleared by the FDA in a patient setting 

• What does it mean if a respirator is approved by NIOSH and cleared by the FDA 

Is a surgical mask an N95 respirator 

No. Surgical masks are not designed for use as particulate respirators and do not provide as much respiratory 

protection as an N95 respirator. Surgical masks provide barrier protection against droplets including large respiratory 

particles. Most surgical masks do not effectively filter small particles from the air and do not prevent leakage around 

the edge of the mask when the user inhales. 2 The NIOSH Science Blog: N95 Respirators and Surgical Masks, posted 

10/15/2009, provides an explanation of the science behind and the similarities/differences between NIOSH-approved 

particulate respirators and surgical masks. 

2 Reference: Rengasamy,S., B.C.Eimer, and R.E.Shaffer. (2009) Filtration performance of FDA-Cleared surgical 

masks. Journal International Society Respiratory Protection 26; 54-70. 

OSHA Video: The Difference Between Respirators and Surgical Masks (scroll down page) 

The Difference Between Respirators and Surgical Masks. U.S. Department of Labor Video, (2009, December 16). 

This video is available in English and Spanish and is available for downloading. 

What is a surgical N95 respirator 

A surgical N95 respirator is a NIOSH-approved N95 respirator that has also been cleared by the Food and Drug 

Administration (FDA) as a surgical mask. These products are noted in red font on the table of NIOSH-approved N95 

respirators. For your convenience, a comprehensive table of these products appears below. If you have a product 

that you believe is FDA cleared that does not appear on this table, you should verify the FDA clearance by contacting 

the FDA at 1-800-638-2041. 

The National Institute for Occupational Safety and Health (NIOSH) is the U.S. Government agency responsible for 

the certification and approval of respiratory protective devices for occupational use. The authority is granted to 

NIOSH in accordance with conditions and standards established in Title 42 of the Code of Federal Regulations 

(CFR), Part 84. It also addresses quality assurance requirements for the manufacturing of respiratory protective 

equipment. The approach to approval is that anybody can manufacture and sell any type of respiratory protective 

device, but only those that meet or exceed all of the requirements established in the 42 CFR 84 standards are 

acknowledged by NIOSH, and only those that have been NIOSH certified may be marketed as a NIOSH-approved 

respirator.

The Food and Drug Administration (FDA) is the U.S. Government agency that oversees most medical products, 

foods, and cosmetics. Within the FDA, the Center for Devices and Radiological Health (CDRH) oversees the safety 

and effectiveness of medical devices. Medical devices intended for use in preventing and treating disease is subject 

to regulation under the device provisions of the Federal Food, Drug, and Cosmetic Act. This includes surgical masks 

and surgical N95 respirators. The FDA has no role in the approval or clearance of N95 respirators not intended for 

use as a medical device. 

This table of Surgical N95's is provided as a courtesy. If you have a product that you believe is FDA cleared that does 

not appear on this table, you should verify the FDA clearance by contacting the FDA at 1-800-638-2041. 

Supplier/ 

Manufacturer 

Contact 

Information 

Model Number/ 

Product Line 

Approval 

Number 

Valve 

Yes or 

No 

Manufacturer's 

Donning 

Procedure 

User Instructions 

3M Company 

(Distribution availability for all 

products listed for 3M) 

888-3M HELPS or web 

form 

1860 (FDA) 84A-0006 No 

PDF Only 

72 KB (4 pages) 

3M Company 

888-3M HELPS or web 

form 

1870 (FDA) 84A-3844 No PDF Only 

190 KB (1 page) 

Aearo Corporation 


products listed for Aearo 

Corporation) 

800-444-4774 Pleats Plus (FDA) 

N951050 (FDA) 

1050S (FDA) 

1051 (FDA) 

1051S (FDA) 

1052 (FDA) 

84A-2630 No 

PDF Only 

205 KB (1 page) 

Aearo Corporation 800-444-4774 N9504C (FDA) 

N9504CS (FDA) 

84A-3715 No 

PDF Only 

14 KB (1 page) 

Aearo Corporation 800-444-4774 N9514C (FDA) 84A-4272 No 

PDF Only 


Aearo Corporation 800-444-4774 Pleats Plus (FDA) 

1054S (FDA) 

1054 (FDA) 

84A-4320 No 

PDF Only 

205 KB (1 page) 

Alpha Pro Tech 


products listed for Alpha Pro 

Tech) 

800-749-1363 MAS 695 (FDA) 84A-0457 No PDF Only 211 

KB (1 page) 

Cardinal Health [*E] 800-379-9929 N95-ML(FDA) 84A-3323 No PDF Only 842 

KB (1 page) 

Cardinal Health [*E] 800-379-9929 N95-S(FDA) 84A-4107 No PDF Only 5.6 

MB (1 page) 

Dynarex Corporation [*E] 800-379-9929 2295(FDA) 84A-3323 No PDF Only 842 

KB (1 page) 

Dynarex Corporation [*E] 800-379-9929 2296A(FDA) 84A-4541 No PDF Only 5.5 

MB (1 page) 

Emerald Medical Inc. [*E] 610-670-8571 N9500 (FDA) 84A-3323 No 

PDF Only 2.7 

MB (1 page) 

Foss Manufacturing 

Company 

603-929-6000 SpectraShield 

9500(FDA) 

84A-5199 No 

PDF Only 577 

KB (1 page)

GlaxoSmithCline 

Consumer Healthcare [*C] 

800-821-7236 ActiProtect UF 

(FDA) 

84A-5163 No PDF Only 


Handen Heng Yong 

Protective 

and Clean Products 

Company, Ltd. 

86-311-8551-8218 

86-311-8551-8968 

HY8510 (FDA) 84A-4276 No 

PDF Only 

105 KB (1 page) 

Handen Heng Yong 

Protective 

and Clean Products 


86-311-8551-8218 

86-311-8551-8968 

HY9810 (FDA) 84A-4521 No 

PDF Only 

114 KB (1 page) 

Inovel, LLC [*J] 


products listed for Inovel, LLC) 

800-421-0668 1511 (FDA) 

1512 (FDA) 

1513 (FDA) 

1517 (FDA) 

Obsolete 08/2009 

84A-0013 No Donning Procedure 


Inovel, LLC 800-421-0668 1510 (FDA) 84A-4333 No Donning Procedure 


Inovel, LLC 866-546-6835 3211N95-S (FDA) 

321N95-M/L (FDA) 

3217N-95-LP (FDA) 

Inovel, LLC 866-546-6835 FRN95-S (FDA) 

FRN95-ML (FDA) 

FRN95-A (FDA) 

FRN95-XS (FDA) 

Inovel, LLC 866-546-6835 FRN95-SEZ (FDA) 

FRN95-MLEZ 

(FDA) 


3002N95-M (FDA) 

3003N95-L (FDA) 

3004N95-LP (FDA) 


3102N95-M/L 

(FDA) 











Kimberly-Clark 

Corporation 

800-524-3577 46827 (FDA) 

46867 (FDA) 

84A-0005 No 

PDF Only 

2 MB (8 pages) 

Kimberly-Clark 

Corporation 

800-524-3577 46727 (FDA) 

46767 (FDA) 


2 MB (8 pages) 

Louis M. Gerson Company, 

Inc. 


products listed for Louis M. 

Gerson Company, Inc.) 

800-225-8623 1730 (FDA) 84A-0160 No PDF Only 

122 KB (1 page) 

Louis M. Gerson Company, 

Inc. 

800-225-8623 2130 (FDA) 

2131 (FDA) 


122 KB (1 page) 

Magid Glove and Safety, 

LLC [*E] 


products listed for Magid Glove 

800-379-9929 910-N95 (FDA) 84A-3323 No 

PDF Only 

842 KB (1 page)

and Safety, LLC) 

Makrite Industries, Inc. 800-379-9929 910-N95 (FDA) 84A-3323 No 

PDF Only 

842 KB (1 page) 

Makrite Industries, Inc. 800-379-9929 910-N95S (FDA) 84A-4107 No PDF Only 

5.6 MB (1 page) 

Makrite Industries, Inc. 800-379-9929 910-N95FMX 84A-4541 No 

PDF Only 5.6 

MB (1 page) 

Medline Industries, Inc. 

[*E] 

800-379-9929 NON24506 84A-3323 No 

PDF Only 842 

KB (1 page) 

Medline Industries, Inc. 

[*E] 

800-379-9929 NON24507 84A-4107 No PDF Only 5.6 

MB (1 page) 

Moldex-Metric, Inc. 


products listed for Moldex- 

Metric, Inc.) 

800-421-0668 1511 (FDA) 

1512 (FDA) 

1513 (FDA) 

1517 (FDA) 



Moldex-Metric, Inc. 800-421-0668 2210GN95-XS 

(FDA) 

2211GN95-S (FDA) 

2212GN95-M/L 

(FDA) 

2217GN95-LP 

(FDA) 



Moldex-Metric, Inc. 800-421-0668 1510 (FDA) 84A-5171 No Donning Procedure 


Moldex-Metric, Inc. 800-421-0668 3211N95-S (FDA) 

3212N95-ML (FDA) 

3217N95-LP (FDA) 



Moldex-Metric, Inc. 800-421-0668 1712 (FDA) 84A-5227 No 

PDF Only 


Precept Medical Products 

[*E] 

Precept Medical Products 

[*E] 

800-379-9929 65-3395 (FDA) 84A-3323 No 

800-379-9929 65-3395S (FDA) 84A-4107 No 

PDF Only 

182 KB (1 page) 

PDF Only 

182 KB (1 page) 

Prestige Ameritech 866-401-8972 RP88020 (FDA) 84A-5216 No PDF Only 256 

KB (1 page) 

Safe Life Corporation 858-794-3200 B130 (FDA) 84A-5200 No PDF Only 759 

KB (1 page) 

Safe Life Corporation 858-794-3200 B150 (FDA) 84A-5201 No 

PDF Only 759 

KB (1 page) 

Shanghai Dasheng Health 

Products 

Manufacture Company, 

Ltd. 

86-21-5778-3126 DTC3M-1 

(FDA) 

84A-4331 No PDF Only 247 

KB (1 page) 

Shanghai Dasheng Health 86-21-5778-3126 DTC3B 84A-4336 No PDF Only 247

Products 

Manufacture Company, 

Ltd. 

(FDA) 

KB (1 page) 

Shanghai Gangkai 

Purifying Products 



products listed for Shanghai 

Gangkai Purifying Products 

Company, Ltd.) 

86-21-5777-5401 GIKO 1400 (FDA) 84A-4282 No PDF Only 


Shuenn Bao Shing 

Corporation 

Shuenn Bao Shing 

Corporation 

886-4-875-6141 AP0018 N95 (FDA) 84A-4049 No 

886-4-875-6141 AP0028 (FDA) 84A-4175 No 

PDF Only 


PDF Only 


Sperian Respiratory 

Protection USA, LLC 


products listed for Sperian 

Respiratory Protection USA, 

LLC) 

800-821-7236 

800-343-3411 

information@ 

sperianprotection.com 

1930 (FDA) 84A-0301 No 

PDF Only 




800-821-7236 

800-343-3411 

information@ 


1940 (FDA) 84A-0301 No 

PDF Only 






800-821-7236 

800-343-3411 

information@ 


800-821-7236 

800-343-3411 

information@ 


HC-NB095 (FDA) 84A-4357 No PDF Only 


HC-NB295F (FDA) 84A-4371 No PDF Only 




800-821-7236 

800-343-3411 

information@ 


HC-NB095F (FDA) 84A-4372 No 

PDF Only 


C - Private label of Sperian (800-821-7236) 

E - Private label of Makrite Industries, Inc. (800-749-1363) 

J - Private label of Moldex-Metric, Inc. (800-421-0668) 

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Can the products with an exhalation valve be used in healthcare 

Respirators with exhalation valves can be used in a healthcare setting when it is not important to maintain a sterile 

field (an example of an acceptable practice would be when taking the temperature or blood pressure of a patient). 

Respirators with exhalation valves should not be used in situations where a sterile field is required (e.g. during an 

invasive procedure in an operating or procedure room) because the exhalation valve allows unfiltered exhaled air to 

escape into the sterile field. 

Do N95 respirators come in different sizes

Yes. The sizing differs with each respirator model. Some of the sizing options include small, small/medium, medium, 

medium/large, and large. Particulate filtering facepiece respirators, including those commonly referred to as N95s, 

are available in multiple size configurations that are variable and not standardized across models. 

How do I know what size I need 

Fit testing is needed to determine if a particular size and model of respirator provides you with an acceptable fit. Fit 

testing is model specific. Before you wear a respirator in an occupational setting, you must be fit tested in each 

respirator model you will wear. 

Do N95 respirators come in different styles 

Yes. Filtering facepiece respirators are available in a wide range of colors, shapes, and styles. Some styles will fit 

individuals better than others and certain styles may be more comfortable and have better fitting characteristics. As 

long as the N95 is NIOSH-approved, has been fit tested, and is being used in accordance with the requirements of an 

OSHA-compliant respirator program, including appropriately donned by the user, then the wearer should receive the 

expected protection factor regardless of color, shape, or style. 

Below are some of the styles available.

Photos courtesy of 3M, Kimberly-Clark, and Moldex. 

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Why do some N95 respirators have an exhalation valve on the front 

The use of an exhalation valve reduces exhalation resistance, which makes it easier to breathe (exhale). Some users 

feel that a respirator with an exhalation valve keeps the face cooler and reduces moisture build up inside the 

facepiece. 

Does moisture build up in respirators 

The wearer’s respiratory secretions and moist exhaled breath can lead to moisture build-up in a respirator. While it is 

possible for moisture to build up in a respirator with or without an exhalation valve, preliminary research shows that 

this is unlikely. 

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What are the differences among these products 

Surgical, Medical, or Procedure Mask N95 Respirator Surgical N95 Respirator 

Standard Earloop Mask 

Photo courtesy of Newton Safety/Sanax 

Molded Cup Style N95 respirator 

Photo courtesy of Sperian 

Molded Cup Style Surgical N95 

respirator 

Photo courtesy of Sperian


Standard Tie On Surgical Mask 


Pleated style N95 respirator 

Photo courtesy of Alpha TechPro 

Duck bill style Surgical N95 

Photo courtesy of Kimberly Clark 

Duckbill surgical mask 

Flexwing style, one strap N95 


Photo courtesy of Moldex 

Flexwing style, one strap, 

Duramesh cover Surgical N95 


Photo courtesy of Moldex 

Molded Cone Surgical Mask 

Photo courtesy of 3M 

Photo courtesy of 3M 

Cup Style Surgical N95 

respirator (interior and exterior 

view) 

Photo courtesy of Louis Gerson 

Evaluation, Testing and Certification 

Cup Style and Flat Fold N95 

Respirators 


Filter efficiency, breathing resistance, fluid Evaluated, tested and certified by Evaluated, tested and certified


resistance and flammability data are 

reviewed by the FDA. Must demonstrate 

filtration efficiency no less than another 

surgical mask already cleared by the 

FDA. (the minimum filtration level is 

unspecified). 

Intended Use 

A surgical mask is intended to prevent the 

release of potential contaminants from the 

user into their immediate environment. It 

is also used to protect the wearer from 

large droplets, sprays and splashes of 

body fluids. 

Purpose 

Barrier to splash, droplets, spit. 

Face Seal Fit 

Not designed to fit tight to face. 

User Seal Check Requirement 

Not designed for seal check. 

Filtration 

Does not effectively filter small particles 

from air. 

Leakage 

Leakage occurs around the edge of the 

mask when the user inhales. 

NIOSH as per the minimum 

performance requirements like filter 

efficiency and breathing resistance. 

NIOSH approves 9 filter classes of 

which N95 is the lowest. 

Occupational (including medical) use. 

Reduces wearer’s exposure to 

particles including small particle 

aerosols and large droplets (all nonoil 

aerosols). 

Protects from exposure to airborne 

particles. In a healthcare setting, 

protects from exposure to biological 

aerosols including viruses and 

bacteria. 

Designed to fit tight to face creating a 

seal around the perimeter of the 

respirator to improve protection. 

Required each time a respirator is 

donned. 

Effectively filters large and small 

particles from air. 

When properly fitted and donned, 

minimal leakage around edges of the 

respirator when the user inhales. 

by NIOSH as per the minimum 

performance requirements as an 

N95 filtering facepiece 

respirator. 

FDA accepts filter efficiency and 

breathing resistance based on 

NIOSH test results from the 

NIOSH approval evaluation, and 

reviews fluid resistance and 

flammability data submitted by 

the manufacturer for clearance 

of the N95 respirator as a 

medical device for use in a 

surgical setting. 

Can be used in any occupational 

setting where an N95 respirator 

is appropriate. Medical use 

where a sterile field needs to be 

maintained. Reduces wearer’s 

exposure to certain airborne 

particles (all non-oil aerosols) 

and provides a barrier to 

splashes and sprays. 

Protects from exposure to 

airborne particles and barrier to 

splashes, droplets, and sprays. 

In a healthcare setting, protects 

from exposure to biohazards 

including viruses and bacteria. 

Designed to fit tight to face 

creating a seal around the 

perimeter of the respirator to 

improve protection. 

Required each time a respirator 

is donned. 

Effectively filters large and small 

particles from air. 

When properly fitted and 

donned, minimal leakage around 

edges of the respirator when the 

user inhales.


Use Limitations 

One time use (one patient encounter). 

Available sizes 

Generally only one size. 

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Single use. Should be discarded 

when it becomes damaged or 

deformed; no longer forms an 

effective seal to the face; becomes 

wet or visibly dirty; breathing through 

it becomes more difficult; or if it 

becomes contaminated with blood, 

respiratory or nasal secretions, or 

other bodily fluids from patients. 

Available in multiple size 

configurations. However, sizing is not 

standardized among approved 

models. Some of the sizing options 

include small, small/medium, 

medium, medium/large, and large. 

Single use. Should be discarded 

when it becomes damaged or 

deformed; no longer forms an 

effective seal to the face; 

becomes wet or visibly dirty; 

breathing through it becomes 

more difficult; or if it becomes 

contaminated with blood, 

respiratory or nasal secretions, 

or other bodily fluids from 

patients. 

Available in multiple size 

configurations. However, sizing 

is not standardized among 

approved models. Some of the 

sizing options include small, 

small/medium, medium, 

medium/large, and large. 

How long can you wear the same N95 respirator 

The current NIOSH service-time-limit recommendations for non-powered particulate filter respirators are that filter 

elements should be replaced at the following frequencies: 

• The service life of all filters on NIOSH-approved respirators is limited by considerations of hygiene, damage, 

and breathing resistance. All filters should be replaced whenever they are damaged, soiled, or causing 

noticeably increased breathing resistance. 

• N-series filters generally should be used and reused subject only to considerations of hygiene, damage, and 

increased breathing resistance. However, for dirty workplaces that could result in high filter loading (i.e., 200 

mg), service time for N-series filters should only be extended beyond 8 hours of use (continuous or 

intermittent) by performing an evaluation in specific workplace settings that demonstrates: (a) that extended 

use will not degrade the filter efficiency below the efficiency level specified in 42 CFR 84, or (b) that the total 

mass loading of the filter(s) is less than 200 mg. These determinations would need to be repeated whenever 

conditions change or modifications are made to processes that could change the type of particulate 

generated in the user's facility. 

• For healthcare applications where use is for protection against confirmed or suspected 2009 H1N1 

influenza, please refer to: Interim Guidance on Infection Control Measures for 2009 H1N1 Influenza in Healthcare 

Settings, Including Protection of Healthcare Personnel. 

Can a N95 respirator be used from Operating Room (OR) case to OR case or from patient to 

patient 

Used respirators are considered contaminated and ideally should be discarded after each patient encounter. 

Disposable N95 respirators worn during aerosol-generating procedures should be discarded after the procedure. 

Healthcare facilities can extend the use of disposable N95 respirators by training personnel to wear them during 

serial patient encounters without removing or re-donning between encounters. There is the risk of respirator 

contamination and contact transmission with this practice where extended use of disposable N95 respirators could 

entail a risk of contact transmission by touching a contaminated surface of the respirator and subsequently touching 

the mucous membranes of the face or a hypothetical risk of re-aerosolization of virus from a used respirator. The risk 

will be minimized if HCWs perform hand hygiene every time before and after touching the respirator.

For healthcare applications where use is for protection against confirmed or suspected 2009 H1N1, please refer to 

Interim Guidance on Infection Control Measures for 2009 H1N1 Influenza in Healthcare Settings, Including Protection 

of Healthcare Personnel and Questions & Answers Regarding Respiratory Protection for Infection Control Measures 

for 2009 H1N1 Influenza among Healthcare Personnel for recommendations for the duration of wear for protection 

against the 2009 H1N1 exposure hazards. 

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Is cross contamination a concern if I wear the same N95 from patient room to patient room 

Yes, especially if the respirator was worn in a room with any type of aerosol generating procedure, or if the patient is 

suspected of or confirmed with having the 2009 H1N1 virus. Although this practice has the potential benefit of 

providing respiratory protection with limited supplies of respirators, there is the risk of respirator contamination and 

contact transmission. Extended use (i.e. use without removing or re-donning between encounters) of disposable N95 

respirators could entail a risk of contact transmission by touching a contaminated surface of the respirator and 

subsequently touching the mucous membranes of the face or a hypothetical risk of re-aerosolization of virus from a 

used respirator. The precise balance between risk of contact transmission and benefit of extended use is unknown, 

although the risk will be minimized if HCWs perform hand hygiene every time before and after touching the respirator. 

In general, wearing an N95 respirator over multiple encounters (while minimizing touching, removing, or re-donning 

between encounters) would be favored over re-use, as this strategy is expected to involve less touching of the 

respirator and therefore less risk of contact transmission. For healthcare applications where use is for protection 

against confirmed or suspected 2009 H1N1, please refer to Interim Guidance on Infection Control Measures for 2009 

H1N1 Influenza in Healthcare Settings, Including Protection of Healthcare Personnel and Questions & Answers 

Regarding Respiratory Protection for Infection Control Measures for 2009 H1N1 Influenza among Healthcare 

Personnel for recommendations for the duration of wear for protection against the 2009 H1N1 exposure hazards. 

Can I take a N95 respirator off in between patients or Operating Room cases 

Used respirators are considered contaminated and ideally should be discarded after each patient encounter. A user 

should never touch the contaminated front of the respirator with his or her bare hands. Hands should always be 

washed after donning and doffing the respirator. Healthcare facilities implementing steps to extend the existing supply 

of disposable N95 respirators by training personnel to re-use them (i.e. removing and re-donning between patient 

encounters) refer to Questions & Answers Regarding Respiratory Protection for Infection Control Measures for 2009 

H1N1 Influenza among Healthcare Personnel for recommendations for the possible re-use of respirators between 

patient encounters when used for protection against the 2009 H1N1 exposure hazards. 

How should I store my N95 in between patient encounters, in a healthcare setting 

The manufacturers provide instructions for cleaning, sanitizing, repairing, inspecting, and storing their respirators. The 

respirators should be packed or stored so that the respirators do not become damaged or deformed. Never store 

disposable respirators in pockets, plastic bags, or other confined areas. Infectious material deposited on personal 

protective equipment may cause it to become a vehicle for direct or indirect transmission. In those situations, care is 

needed when removing and storing personal protective equipment to avoid contaminating skin, clothing, and mucous 

membranes. Remove the respirator and either hang it in a designated area or place it in a bag. (Consider labeling 

respirators with a user’s name before use to prevent reuse by another individual.) In healthcare settings where the 

patients have confirmed or suspected 2009 H1N1 influenza, please refer to Questions & Answers Regarding 

Respiratory Protection for Infection Control Measures for 2009 H1N1 Influenza among Healthcare Personnel for 

recommendations for the possible storage of respirators between patient encounters when used for protection 

against the 2009 H1N1 exposure hazards. 

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Can I infect myself from the droplets that accumulate on the outside of the respirator 

Respirators protect by capturing particles with the filter of the N95 respirator. Some aerosols can pose a contact 

hazard for infection. The accumulation of particles on the external surface of the respirator may be an exposure 

hazard from contact with the filter, including becoming a fomite for infectious agents. Users should be cautious and 

follow appropriate procedures to avoid self-inoculation from contact with these surfaces. Hand hygiene and infection

control practices should be followed before and after touching the outside of the respirator when it is used in the 

presence of infectious agents. 

Do I need special training to wear an N95 or do I put it on and wear it like a surgical mask 

The NIOSH certification requires respirators to be put on, used and maintained in accordance with the manufacturer 

instructions and a respiratory protection program that meets the requirements of the OSHA respiratory protection 

standard (29 CFR 1910.134). Training for all users is a mandatory part of OSHA’s respirator program requirements. 

Training is usually done at the same time that fit testing takes place. The OSHA standard contains required training 

elements. The manufacturer instructions for donning and doffing for each brand and model may be model-specific 

and must be followed. These instructions are located in the User Instructions provided, on the box or individual 

package of the respirators. The manufacturer’s instruction for putting on (donning) the respirator is also included in 

the information provided in the NIOSH listing for approved disposable respirators. 

Can we use an N95 that has not been cleared by the FDA in a patient setting 

NIOSH-certified N95 respirators that have not been cleared by the FDA can be used for respiratory protection to 

reduce the exposures of healthcare personnel in a patient setting to hazardous particulates. These respirators have 

not been evaluated by FDA to determine whether they meet the fluid and flammability resistance as required for FDA 

clearance as medical devices. For this reason, they are not intended for use in exposure settings where the 

performance of a surgical mask to maintain a sterile field is required. 

What does it mean if a respirator is approved by NIOSH and cleared by the FDA 

N95 respirators that are both certified by NIOSH and cleared by FDA as medical devices for use by healthcare 

personnel are called “surgical N95 respirators.” As with all NIOSH-certified N95 respirators, these products have 

been evaluated by NIOSH certification process and have demonstrated that they can filter out a minimum of 95% of 

airborne particles under worse case test conditions. These products have also been evaluated by the FDA to have 

demonstrated an acceptable level of fluid and flame resistance, which may be important in healthcare occupational 

settings, such as surgical suites. The FDA clearance process also requires that these products have labeling that is 

relevant to healthcare personnel, such as information about the presence of natural rubber latex. 

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Medical Evaluation FAQs 

• Are medical evaluations a must 

• Is a medical evaluation required for voluntary use of a respirator (i.e., when respirator use is not required by your 

employer) 

• Can the medical evaluation be completed when fit testing is performed or does it have to be completed prior Does it 

have to be done by a physician 

• How frequently does the medical evaluation have to be completed 

Are medical evaluations a must 

Yes, a medical evaluation is an element of the written respiratory protection program that is required by the 

Occupational Safety and Health Administration (OSHA) (29 CFR 1910.134). The standard requires that if you are 

required to wear a respirator due to a potential hazard in your work environment, you must be fit-tested, trained, and 

medically evaluated prior to having a respirator issued. 

Is a medical evaluation required for voluntary use of a respirator (i.e., when respirator use is not 

required by your employer) 

It depends on the type of respirator to be worn. A written respirator program, including medical evaluation, is required 

for the voluntary use of any respirator except filtering facepiece respirators. An N95 respirator often used by 

healthcare personnel is an example of a filtering facepiece respirator.

Can the medical evaluation be completed when fit testing is performed or does it have to be 

completed prior Does it have to be done by a physician 

The medical evaluation determines your ability to use a respirator. It is required to be completed before you are fit 

tested and before the decision is made that you are required to use a respirator in the work environment. It is 

mandatory that you be evaluated by a physician or other licensed healthcare professional (PLHCP) who provides a 

written recommendation regarding your ability to use respirators. The physician or other licensed healthcare 

professional (PLHCP) needs to be an individual whose legally permitted scope of practice (i.e., license, registration, 

or certification) allows him or her to independently provide, or be delegated the responsibility to provide, some or all 

of the healthcare services required in the medical evaluation. 

If your employer opts to perform medical evaluations utilizing a medical questionnaire, the completed questionnaire is 

sent to the healthcare professional for review. Depending on your answers to the questionnaire, you may be required 

to have a follow-up medical evaluation before being allowed to wear a respirator. 

How frequently does the medical evaluation have to be completed 

Medical evaluation is required once, prior to initial fit testing and use, if you are required to use a respirator in your 

workplace. However, the medical evaluation may need to be repeated if you, your supervisor, or your respiratory 

program administrator recognize signs or symptoms that may affect your ability to use the assigned respirator, or a 

physician or other licensed healthcare professional (PLHCP), determines that a condition exists which causes you to 

need another medical evaluation. 

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Selection FAQs 

• What is the appropriate respirator to use in a particular environment 

• What do you do with employees who have facial hair (What if the beard or mustache is small enough that it is 

contained inside the respirator) 

• What is the difference between air-purifying and air-supplied respirators 

• What is the difference between a filtering facepiece respirator and an elastomeric 

• We are having a hard time getting our usual brand of N95 respirators. If we purchase another brand or model, do we 

need to fit test all of our employees again 

• Respirator Manufacturer Prior Names 

• Can I use an N95 filtering facepiece respirator for protection against exposures to gases or vapors, such as 

glutaraldehyde or formaldehyde 

• Why do I need to know the concentration of a contaminant that may present an inhalation hazard 

• How do I figure out what protection I need the respirator to provide Why can’t I just buy a respirator that will protect 

me from everything 

What is the appropriate respirator to use in a particular environment 

Your employer is responsible for selecting an appropriate respirator for you. Your employer’s designated respiratory 

protection program administrator can assist you with respirator selection. He/she administers and oversees the 

respiratory protection program at your workplace according to the Occupational Safety and Health Administration’s 

(OSHA) respiratory protection standard at (29 CFR 1910.134). 

The following resources may also be helpful: 

• A series of questions in the NIOSH Respirator Selection Logic Sequence that will allow you to determine the 

appropriate class of respirator to use. 

• The NIOSH Trusted-Source web page for more information on everything about respirators. 

• Frequently Asked Questions (FAQs) on Respiratory Protection Program.

What do you do with employees who have facial hair (What if the beard or mustache is small 

enough that it is contained inside the respirator) 

Tight-fitting respirators require the wearer’s face to be clean shaven where the respirator’s seal comes in contact with 

the skin. If the facial hair does not extend far enough to interfere with the device’s seal in any way, or interfere with 

the function of the exhalation valve, the wearer may wear it with the approval of the respiratory protection 

administrator. Loose-fitting respirators, such as Powered Air-Purifying Respirators (PAPRs) with loose-fitting hoods, 

do not form a tight seal with the face and, therefore, do not require the wearer to have a clean shaven face. Loosefitting 

respirators (i.e. respirators with loose-fitting hoods or helmets) are the only type of respirators that may be worn 

with facial hair and do not require fit testing. 

What is the difference between air-purifying and air-supplied respirators 

Air-purifying respirators (APR) work by removing contaminants from the air. APRs include particulate respirators, 

which filter out airborne particles, and “gas masks,” which filter out vapors and gases. Air-supplying respirators (ASR) 

protect employees by supplying clean breathable air from another source. ASRs include airline respirators, which use 

compressed air from a remote source; and self-contained breathing apparatuses (SCBAs), which include their own 

air supply. View more information about air-purifying and air-supplied respirators. 

What is the difference between a filtering facepiece respirator and an elastomeric 

As the name implies, a filtering facepiece respirator is one in which the entire facepiece is comprised of the filter 

material. Elastomeric respirators are comprised of a molded facepiece to which replaceable filtering cartridges are 

attached. View more details and photos of the different types of respirators. 

We are having a hard time getting our usual brand of N95 respirators. If we purchase another 

brand or model, do we need to fit test all of our employees again 

Yes. A fit test only qualifies the user to put on (don) one specific brand/make/model/size of respirator. However, it is 

only necessary to fit test those employees whose duties require them to wear a respirator. Therefore, you may not 

need to fit test “all” of your employees. If “all” employees are likely to be at risk of exposure to airborne contaminants 

you may want to consider a phased in fit testing program allowing the facility to have more time to eventually properly 

fit test the employees. 

You should only wear the specific brand, model, and size respirators you wore during successful fit tests. [Note: 

respirator sizing is variable and not standardized across models or brands. For example, a medium in one model may 

not offer the same fit as a different manufacturer’s medium model.] 

Respirator Manufacturer Prior Names 

Due to the transitive nature of company holdings, if the manufacturing company you are looking for does not appear, 

please refer to the parent company listed under the notes column for product information. A list of Respirator 

Manufacturer Prior Names is provided as a service to users and may not be all inclusive due to NIOSH not being 

notified of name changes, mergers, etc. 

Can I use an N95 filtering facepiece respirator for protection against exposures to gases or 

vapors, such as glutaraldehyde or formaldehyde 

N95 filtering facepiece respirators do not provide protection against gas and vapor exposures. N95 filtering facepiece 

respirators should not be used for respiratory protection in workplaces where hazardous gases or vapors are present, 

unless the concentration of the gases or vapors is below the NIOSH recommended exposure limit (REL) or OSHA 

permissible exposure limit (PEL). An N95 is designed to remove particles from the air you breathe, such as metal 

fumes (for example, fumes cause by welding), mineral or dust particles, or even biological particles like viruses; 

however, it will do nothing to remove glutaraldehyde, formaldehyde, or other gases or vapors. If harmful gases are 

present in amounts greater than the exposure limits, you will probably need a respirator that uses special cartridges 

or canisters containing specially treated charcoal to remove the harmful gas before you inhale it into your lungs. To

find what level of a particular chemical is harmful and what protection you should use, consult the NIOSH Pocket 

Guide to Chemical Hazards or the chemical’s Material Safety Data Sheet (MSDS). 

Why do I need to know the concentration of a contaminant that may present an inhalation hazard 

The concentrations of harmful gases, vapors, or particulates is part of the information used to determine what type of 

respiratory protection (i.e., the class of respirator) is needed to protect you from inhaling them in hazardous 

concentrations. The concentrations of infectious bioaerosols are generally not easily measured or determined. 

Therefore, the determination of an appropriate type of respiratory protection to be used for bioaerosol exposures is 

generally made using professional judgment. 

How do I figure out what protection I need the respirator to provide Why can’t I just buy a 

respirator that will protect me from everything 

An air-purifying respirator (APR) that would remove all types of hazardous contaminants from the air you breathe 

(universal respiratory protection) just does not exist. The respirator that comes closest would be an air-supplying 

respirator (ASR), which uses “clean” breathing air either from a remote source or carried by the wearer. ASRs are 

either self-contained breathing apparatus (SCBA) with cylinders of breathing gases or supplied air respirators (SAR), 

also known as airline respirators that use air supplied from a remote location. For most healthcare situations, ASRs 

require significantly more maintenance and provide much higher protection than needed for the respiratory hazards. 

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Fit Test FAQs 

• What is a respirator fit test 

• Why is fit testing necessary 

• Are there different methods for respirator fit testing 

• What is the difference between a qualitative and quantitative fit test 

• How is qualitative fit testing performed 

• How is quantitative fit testing performed 

• Are respirator fit tests required 

• How often must fit testing be done 

• Once I am fit tested can I use any brand / make / model respirator as long as it is the same size 

• What is a respirator user seal check 

• When should a user seal check be done 

• How do I do a user seal check on a particulate respirator 

• Do Powered Air-Purifying Respirators (PAPRs) require fit testing 

What is a respirator fit test 

A fit test is a test protocol conducted to verify that a respirator is both comfortable and correctly fits the user. Fit 

testing uses a test agent, either qualitatively detected by the wearer’s sense of taste, smell or involuntary cough 

(irritant smoke) or quantitatively measured by an instrument, to verify the respirator’s fit. See questions related to 

qualitative and quantitative fit testing for more specific information. 

Why is fit testing necessary 

Fit testing each model of respirator the employee is to use in workplace tasks before their use is important to assure 

the expected level of protection is provided by minimizing the total amount of contaminant leakage into the facepiece. 

The benefits of this testing include better protection for the employee and verification that the employee is wearing a 

correctly-fitting model and size of respirator. Higher than expected exposures to a contaminate may occur if users 

have poor face seals with the respirator, which can result in excessive leakage. 

Are there different methods for respirator fit testing

Yes. Fit test methods are classified as either qualitative or quantitative, and there are multiple protocols of each 

classification that are OSHA-accepted, ANSI-accepted, or NIOSH-recommended. A qualitative fit test is a pass/fail 

test to assess the adequacy of respirator fit that relies on the individual’s sensory detection of a test agent. A 

quantitative fit test numerically measures the effectiveness of the respirator to seal with the wearer’s face, without 

relying on the wearer’s voluntary or involuntary response to a test agent. 

What is the difference between a qualitative and quantitative fit test 

Qualitative fit testing (QLFT) relies on the respirator wearer’s senses to determine if there is a gap in the seal of the 

respirator to the wearer’s face. 

The test agents used in the OSHA-accepted and ANSI-accepted qualitative fit testing protocols are: 

• Saccharin – a sweet tasting solid aerosol; 

• Isoamyl acetate – a liquid that produces a sweet smelling vapor similar to bananas; 

• BitrexTM – a bitter tasting solid aerosol; and 

• Irritant smoke – a solid aerosol made of stannic oxychloride that produces hydrochloric acid when it comes 

in contact with water vapor. Exposure to the hydrochloric acid produces an involuntary cough reflex. [Note: 

NIOSH does not endorse or recommend the use of the irritant smoke fit test. NIOSH, in its formal comments 

to OSHA on the proposed revision of 29 CFR 1910, 1915, and 1926, strongly recommended against the use 

of this fit test method because of the health risk associated with exposure to the irritant smoke. That 

recommendation was primarily based on studies conducted as part of a NIOSH HHE (HETA 93-040-2315) 

and described in Appendix A of the NIOSH comments to OSHA dated May 15, 1995 (docket H-049).] 

The test protocols include testing at a sensitivity level that demonstrates the user will be able to appropriately sense 

the presence of the test agent within the respirator by taste, smell or the urge to cough. 

Quantitative fit testing (QNFT) uses fit testing instrument(s) to provide quantitative, or numerical measurements of 

the amount of face seal leakage present when a given respirator is donned by a particular user. 

How is qualitative fit testing performed 

The Occupational Safety and Health Administration (OSHA) has included the acceptance of respirator fit test 

protocols in it’s regulations at 29 CFR 1910.134. The OSHA-accepted fit test protocols can be found at 29 CFR 

1910.134 appendix A. The American National Standards Institute’s ANSI Z88.10, Respirator Fit Testing Methods 

provides the step-by-step explanations for conducting the ANSI-accepted fit tests. While the OSHA regulations and 

ANSI Z88.10 provide the procedures that must be used to conduct each of the accepted protocols, a general 

description of how the protocols are conducted is provided below for the convenience of the reader. 

Qualitative fit testing (QLFT) 

1. The protocols are initiated by first determining the wearer’s ability to detect the test agent (e.g. saccharin, 

isoamyl acetate, BitrexTM) at a sensitivity level that corresponds to less than an acceptable fit before put on 

(donning) the tight-fitting facepiece respirator. The wearer enters an exposure chamber, has a test enclosure 

placed on his/her head, or is positioned somewhere in an open test area and the test agent is generated 

around him/her. The wearer signals when the test agent is sensed. The fit test operator proceeds with the fit 

test only if the demonstrated sensitization level is low enough to assure the test agent will be sensed at all 

levels representing a failure to achieve an acceptable fit. [Note: Isoamyl acetate, being an organic vapor, 

can not be used as a test agent for particulate respirators.] 

2. Next, the wearer follows the manufacturer’s instructions to put on what initially seems to be the best fitting 

respirator provided by the employer. 

3. The wearer then completes a user seal check to confirm that the respirator is properly seated on the face 

4. The wearer then enters an exposure chamber, has a test enclosure placed on his/her head, or is positioned 

somewhere in an open test area. The test agent is generated at the designated test level around the subject. 

5. The fit test operator observes the worker during exposure while directing him/her through a series of 

exercises. The fit test operator notes involuntary coughing (irritant smoke) during the test or asks the wearer 

at the end of the test if he or she smelled or tasted anything at any time during the test. From the test

subject’s response and the fit test operator’s observations, the fit test operator determines a pass/fail 

judgment by which the respirator make, model and size may be assigned to the wearer. 

How is quantitative fit testing performed 

The Occupational Safety and Health Administration (OSHA) has included the acceptance of respirator fit test 

protocols in it’s regulations at 29 CFR 1910.134. The OSHA-accepted fit test protocols can be found at 29 CFR 

1910.134 appendix A. The American National Standards Institute’s ANSI Z88.10, Respirator Fit Testing Methods 

provides the step-by-step explanations for conducting the ANSI-accepted fit tests. There are several methods with 

significantly different protocols for conducting Quantitative fit testing (QNFT). While the OSHA regulations and 

ANSI Z88.10 provide the procedures that must be used to conduct each of the accepted protocols, a general 

description of the most common methods used in the protocols are provided below for the convenience of the reader. 

In order to do these measurements, a small sampling tube is positioned to sample the air within the facepiece of the 

respirator and attached to a fit testing instrument able to calculate the percentage of particles leaking into the 

facepiece. 

1. First, the wearer dons one of the respirator models/sizes provided by the employer that is expected to 

provide a good fit , in accordance with the manufacturer’s instructions 

2. The wearer completes a user seal check to confirm that the respirator is properly seated on his/her face 

3. A fit testing adaptor is affixed to the respirator and the respirator is attached to a fit testing instrument 

through a small sampling tube positioned within the facepiece 

4. The fit test operator then instructs the wearer to go through a series of prescribed exercises while the 

attached fit testing instrument measures the ratio of particles both inside and outside of the respirator. From 

this data, a fit factor for the tested wearer is calculated which will determine whether or not the model, brand, 

and size of the respirator is suitable (passable) to be used regularly by that wearer. 

Are respirator fit tests required 

Yes. The Occupational Safety and Health Administration (OSHA) (29 CFR 1910.134) requires a respirator fit test to 

confirm the fit of any respirator that forms a tight seal on the wear’s face before it is to be used in the workplace. That 

same OSHA respirator standard also prohibits tight fitting respirators to be worn by workers who have facial hair that 

comes between the sealing surface of the facepiece and the face of the wearer. 

How often must fit testing be done 

Because each brand, model, and size of particulate facepiece respirators will fit slightly differently, a user should 

engage in a fit test every time a new model, manufacture type/brand, or size is worn. Also, if weight fluctuates or 

facial/dental alterations occur, a fit test should be done again to ensure the respirator remains effective. Otherwise, fit 

testing should be completed at least annually to ensure continued adequate fit. 

Once I am fit tested can I use any brand / make / model respirator as long as it is the same size 

No. A fit test only qualifies the user to put on (don) the specific brand/make/model of respirator with which an 

acceptable fit testing result was achieved. Users should only wear the specific brand, model, and size respirators that 

he or she wore during successful fit tests. [Note: respirator sizing is variable and not standardized across models or 

brands. For example a medium in one model may not offer the same fit as a different manufacturer’s medium model.] 

What is a respirator user seal check 

It is a procedure conducted by the respirator wearer to determine if the respirator is properly seated to the face. The 

user seal check can be either a positive pressure or negative pressure check, which are generally performed as 

follows: The positive pressure user seal check is where the person wearing the respirator exhales gently while 

blocking the paths for exhaled breath to exit the facepiece. A successful check is when the facepiece is slightly 

pressurized before increased pressure causes outward leakage. The negative pressure user seal check is where the 

person wearing the respirator inhales sharply while blocking the paths for inhaled breath to enter the facepiece. A 

successful check is when the facepiece collapses slightly under the negative pressure that is created with this

procedure. A user seal check is sometimes referred to as a fit check. A user seal check should be completed each 

time the respirator is put on (donned). It is only applicable when a respirator has already been successfully fit tested 

on the individual. 

When should a user seal check be done 

Once a fit test has been done to determine the best model and size of respirator for a particular user, a user seal 

check should be done by the user every time the respirator is to be worn to ensure an adequate seal is achieved. 

How do I do a user seal check on a particulate respirator 

A user seal check may be accomplished by using the procedures recommended by the manufacturer of the 

respirator. This information can be found on the box or individual respirator packaging. There are positive and 

negative pressure seal checks and not every respirator can be checked using both. You should refer to the 

manufacturer’s instructions for conducting user seal checks on any specific respirator . 

The following positive and negative user seal check procedures for filtering facepiece respirators are provided as 

examples of how to perform these procedures. 

Positive pressure check –Once the particulate respirator is properly put on (donned), your hands over the facepiece, 

covering as much surface area as possible. Exhale gently into the facepiece. The face fit is considered satisfactory if 

a slight positive pressure is being built up inside the facepiece without any evidence of outward leakage of air at the 

seal. Examples of such evidence would be the feeling of air trickling onto the your face along the seal of the 

facepiece, fogging of your glasses, or a lack of pressure being built up inside the facepiece. 

If the particulate respirator has an exhalation valve, then performing a positive pressure check may be impossible. If 

so, then do a negative pressure check. 

Negative pressure check – Negative pressure seal checks are conducted on particulate respirators that have 

exhalation valves. To conduct a negative pressure user seal check, cover the filter surface with your hands as much 

as possible and then inhale. The facepiece should collapse on your face and you should not feel air passing between 

your face and the facepiece. 

Do Powered Air-Purifying Respirators (PAPRs) require fit testing 

The answer to this question depends on the type of facepiece that the respirator has. Any facepieces that form a tight 

seal to the wearer’s face, e.g. half-masks and full facepieces must be fit tested regardless of the mode of operation. 

The PAPR fit test is conducted with the blower turned off. 

Loose fitting respirators, such as PAPRs, in which the hood or helmet are designed to form only a partial seal with the 

wearer’s face or hoods which seal loosely around the wearer’s neck or shoulders, do not require fit testing. 

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Training FAQs 

• Why do I have to be trained to use a respirator 

• How often do I have to be retrained 

Why do I have to be trained to use a respirator 

Respirators, including filtering facepiece respirators such as N95s, have model-specific user instructions including 

donning instructions and use limitations. Respirators are frequently misused for purposes in which they provide little 

to no protection. It is important to know what respirator to use and how to use it correctly so that it can provide the 

protection that is expected of it. OSHA (29 CFR 1910.134) regulations require that respirator training be provided

prior to requiring an employee to use a respirator in the workplace. The training must be comprehensive, 

understandable, and recur at least annually – or more often if necessary. 

OSHA identifies the following as minimum knowledge a respirator user should have upon completing respirator 

training: 

1. Why the use of a respirator is necessary (e.g., the respiratory hazards and how improper fit, usage, or 

maintenance can compromise the protective effect of the respirator) 

2. The limitations and capabilities of the respirator 

3. How to use the respirator effectively in emergency situations, including when the respirator malfunctions 

4. How to inspect, don (put on) and doff (remove), use, and check the seals of the respirator 

5. The procedures for maintenance and storage 

6. How to recognize medical signs and symptoms that may limit or prevent the effective use of the respirator 

How often do I have to be retrained 

An employee should be trained annually, when exposure conditions change, when a new type or model of respirator 

is issued, or when the employee’s knowledge or use of the respirator indicates the need (e.g. the supervisor observes 

the wearer using the respirator improperly). 

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Donning and Doffing 

• Are all brands and models donned the same 

• Where do I find instructions for putting on (donning) a respirator 

Are all brands and models donned the same 

No. Not all brands and models are donned (put on) the same way. That is why it is important that you always consult 

the manufacturer’s user instructions before putting on (donning) a new brand or model of respirator. Typically, for N95 

particulate respirators, the proper placement of head straps means that the lower strap should be worn around the 

neck and below the ears. The top strap should sit above the ears and around the crown of the head, securing the 

filter piece to the user’s face. The facepiece should feel snug. On most N95 models, the nosepiece is meant to be 

molded to the user’s facial structure using his or her index fingers of both hands to press gently against the metal 

strip until it molds to a snug fit. 

Where do I find instructions for putting on (donning) a respirator 

All respirators should come with manufacturer’s instructions specifically addressing how to properly put on (don) the 

selected respirator to provide expected protection. For more information on this topic please refer to the NIOSH- 

Approved Particulate Filtering Facepiece Respirators web page. Once on the page, select the type of respirator (e.g. 

N95) and it will provide a table with the manufacturer's donning procedure and user instructions for each approved 

respirator model. 

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End-of-service-life FAQs 

• What is end-of-service-life 

• Do respirators have end-of-service-life indicators on them 

• What is the service life of an N95 filter or filtering facepiece respirator 

• How do we calculate a cartridge change out schedule 

• Is canister/cartridge end-of-service life information available on the manufacturers’ website

• If we are using a combination cartridge with a PAPR, how do we know when to change the cartridge Can the cartridge 

be decontaminated to extend its useful life 

• Why do we need to change the respirator cartridge before we can smell something 

• Do we need to throw a filter (used with a PAPR) away when used for/with an H1N1 patient for only one hour 

What is end-of-service-life 

End-of-service-life is when a respirator no longer works correctly. It is when the filtering medium can no longer 

provide the expected level of protection from harmful air contaminants, has reached its capacity for capture and 

retention of the contaminant, when breathing while wearing the respirator becomes too difficult, or when the respirator 

becomes damaged, contaminated, or the integrity of the respirator is no longer intact. 

Do respirators have end-of-service-life indicators on them 

Yes. Some do, for others like the N95 the “indicator” may be the appearance, whether the respirator is damaged, 

contaminated with visible blood or body fluids, or misshapen. For other types of respirators there are specific 

indicators integral in the device. All self-contained breathing apparatuses have an alarm that tells the wearer that 

he/she is going to run out of air from his cylinder and he/she must leave the contaminated area. Some gas- and 

vapor-removing air-purifying respirators are also equipped with end-of-service-life indicators (ESLI). The ESLI are 

usually specific to only one contaminant. The ESLI gives the wearer an indication, often a color change, that the 

contaminant will no longer be able to be removed by the cartridge or canister and that the cartridge or canister should 

be replaced. 

What is the service life of an N95 filter or filtering facepiece respirator 

Unless the manufacturer identifies a specified duration of use, for example “single use only”, the service life of all 

filters is limited by considerations of hygiene, damage, and breathing resistance. All filters should be replaced 

whenever they are damaged, soiled, or causing noticeably increased breathing resistance. Follow manufacturer’s 

recommendations for specific information on the model you are using. 

How is a cartridge change out schedule calculated 

In the absence of an ESLI, a cartridge/canister change out schedule is required for gas- and vapor-removing 

respirators and should be based on objective information or data that will ensure that canisters and cartridges are 

changed before the end of their service life. Usually, manufacturers have software to estimate a change out schedule 

for their cartridges or canisters. Changeout schedules are not the same from one manufacturer’s cartridges or 

canisters to that of another manufacturer. This is because the volume and type of adsorbent varies between 

manufacturers. Additionally, the Occupational Safety and Health Administration (OSHA) has mandatory changeout 

schedules for cartridges for certain substances like acrylonitrile, benzene, butadiene, formaldehyde, vinyl chloride, 

and methylene chloride. Workers depending on respiratory protection who are exposed to any of these contaminants 

at or above the OSHA Permissible Exposure Limit (PEL) must change cartridges/canisters according to OSHA’s 

requirements. In any case, workers should consult their Respirator Program Administrator regarding when to change 

their cartridges/canisters. 

OSHA provides guidance on using mathematical models to predict the service life of organic vapor respirator 

cartridges when used for protection against single contaminants. You can also find the service lives for respirator 

cartridges intended to protect against selected gases already calculated in a table. You can calculate others using 

a computer program called Advisor Genius. OSHA suggests that you reduce the service life estimate by some 

safety factor and document the change schedule in your written respiratory program. 

OSHA has no accepted way to determine a cartridge’s service life when exposed to mixtures; computer models have 

been developed that can estimate service life if you know all the canister physical attributes, environmental factors, 

contaminants and levels, and work rates [Note: Other research has been conducted to develop models for 

contaminant mixtures, but they have not yet been adopted by OSHA.] NIOSH has developed a computer tool for 

estimating breakthrough times and service lives of air-purifying respirator cartridges manufactured to remove toxic 

organic vapors from breathed air that can be used with the cartridge/canister manufacturer’s recommendations for 

multi-gas use of the specific canister/cartridge being used.

If respirators are required in your workplace, OSHA mandates that your employer establish and maintain a respiratory 

protection program that must describe the information and data relied upon and the basis for the canister and 

cartridge change schedule. Because of the complexity of factors involved in determining canister changeout 

schedules, consult your Respirator Program Administrator. 

Is canister/cartridge end-of-service life information available on the manufacturers’ website 

Most manufacturers provide information on their website to help in determining the appropriate changeout schedule 

for their product. 

If I am using a combination cartridge with a PAPR, how do I know when to change the cartridge 

Can the cartridge be decontaminated to extend its useful life 

The training you receive in the use of your assigned respirator as part of your employer’s respiratory protection plan 

will tell you the frequency of cartridge change that has been determined to be appropriate for the conditions in your 

worksite. The Occupational Safety and Health Administration’s Standard for Respiratory Protection (29 CFR 

1910.134) requires employers to implement a change schedule for all cartridges used in the workplace for protection 

against vapors and gases when there isn't an end-of-service- life indicator on the cartridge. This schedule must be 

site specific and take into consideration worksite conditions such as humidity, worker breathing rate, as well as the 

contaminants and their concentrations. 

The cartridge can’t be decontaminated (i.e. reconditioned for reuse). The filter media in the cartridge has a finite 

capacity and the mechanism used to remove the contaminants from the air is usually not reversible. 

Why do we need to change the respirator cartridge before we can smell something 

The purpose of this is to prevent contaminants from breaking through the respirator's sorbent (filtering) cartridge(s), 

and thereby exposing the wearer. Historically, respirator wearers have relied on the warning properties (e.g., odor, 

irritation) of a contaminant as a means to determine when it is time for replacing used cartridges. OSHA no longer 

allows the use of warning properties as the primary basis for changing respirator cartridges. The following factors 

shall be considered when developing a Respirator Cartridge Change Schedule which is required by OSHA and 

should be documented in the Respirator Protection Program: 

• Contaminants 

• Concentration 

• Frequency of use (e.g., continuously, intermittently) throughout the shift 

• Temperature 

• Humidity 

• Wearer’s work rate 

• The presence of potentially interfering chemicals 

Do we need to throw a filter (used with a PAPR) away when used for/with an H1N1 patient for only 

one hour 

Powered air purifying respirator filters used for protection against viruses have no time limit as to their ability to 

remove viruses from the air stream. Their use is subject to other considerations by the infection control or safety 

officer in the healthcare facility. Therefore, it is recommended there be written facility standards for use and disposal 

of these filters. However, filters and cartridges cannot be cleaned, sanitized, or disinfected and should be properly 

disposed of after use. 

At this time, neither the Centers for Disease Control and Prevention (CDC) nor the World Health Organization (WHO) 

have provided any recommendations for cleaning, sanitizing, or disinfecting respirators used for novel H1N1 virus 

exposures. The Occupational Safety and Health Administration (OSHA) requires respirator users to follow either the 

respirator manufacturer’s instructions or OSHA’s general procedures for cleaning respirators in 29 CFR 1910.134 

Appendix B-2; however, OSHA’s procedures are not specific for novel H1N1 virus and may not lead to disinfection.

Refer to the User Instructions for the specific PAPR unit and headgear to identify the components that can be 

cleaned. 

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Respirator Protection Program FAQs 

• Why is it important for me to know who my respiratory protection program administrator is 

• What is a respiratory protection program 

• What is involved/ what comprises/ what components make up a respiratory protection program 

Why is it important for me to know who my respiratory protection program administrator is 

The safety officer, industrial hygienist or designee of your facility, is responsible to run the respiratory protection 

program and evaluate its effectiveness. He/she is trained to identify, assess, and control types of potential inhalation 

hazards in your work area. He/she must be familiar with the Occupational Safety and Health Administration’s (OSHA) 

Respiratory Protection Standard (29 CFR 1910.134) and the use and application of the respirators at the particular 

workplace. Also, he/she is responsible to ensure you are provided with an appropriate and suitable respirator that is 

provided at no cost by the employer to the employee, training, and medical evaluations to protect you from inhaling 

harmful contaminants (contaminants could include biologic agents such as bacteria and viruses). 

If you have questions like whether you should be wearing respiratory protection, what kind of respiratory protection 

you should be wearing, how to maintain this equipment or how to put on or take off this equipment, you should 

contact your administrator. 

What is a respiratory protection program 

A respiratory protection program is a written program required by the Occupational Safety and Health 

Administration’s (OSHA) Respiratory Protection Standard (29 CFR 1910.134). The program includes procedures 

specific to your worksite intended to prevent you from inhaling harmful contaminants in your workplace. OSHA 

requires that each employer must provide respirators to protect workers from workplace hazards during work to 

prevent inhalation of hazardous materials that cannot be controlled by other measures (i.e. engineering or 

administrative controls). The employer must establish and maintain a respiratory protection program, which is 

compliant with the OSHA respiratory protection standard and provides respirators suitable for their intended purpose. 

What is involved/ what comprises/ what components make up a respiratory protection program 

The fundamental goal of any respiratory protection program is to protect workers against any adverse health effect 

caused by inhalation of contaminants in the work environment. The Occupational Safety and Health Administration’s 

(OSHA) Respiratory Protection Standard (29 CFR 1910.134) requires that each respiratory protection program must 

include a written plan detailing how the program will be administered. In addition to having a written program, the 

employer must also be able to demonstrate that the program is enforced and updated as necessary. The OSHA small 

entity compliance guide PDF 707KB (149 pages) is intended to help small businesses comply with the Respiratory 

Protection standard. It provides guidance only, and does not alter or determine compliance responsibilities, which are 

set forth in OSHA standards and the Occupational Safety and Health Act. The written plan includes the following, as 

applicable to address the identified hazards of your worksite (items in bold are required, as applicable, for all 

worksites; and the others are optional): 

• Procedure for selecting respirators for use in the workplace 

• Medical evaluation of employees required to wear respirators 

• Fit testing procedures for tight fitting respirators 

• Procedures for proper use of respirators in routine and reasonably foreseeable emergency situations 

• Procedures and schedules for cleaning, disinfecting, storing, inspecting, repairing, and discarding and 

otherwise maintaining respirators 

• Procedure to ensure adequate quality, quantity and flow of breathing air for atmosphere-supplying air 

respirators

• Training of employees in the proper use of respirators, including putting on and removing them, any 

limitations on their use and their maintenance 

• Procedures for regularly evaluating the effectiveness of the program 

• Procedures for ensuring that workers who voluntarily wear respirators (excluding filtering facepieces) comply 

with the medical evaluation, and cleaning, storing and maintenance requirements of the standard 

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Additional Respiratory Protection Resources 

• CDC / NIOSH 

• Posters from CDC 

• OSHA 

CDC / NIOSH 

Respirator Trusted-Source Information Page 

General Procedures for Properly Putting on and Taking Off a Disposable Respirator 

PDF 5.06 MB (1 page) 

Guidance for the Selection and Use of Personal Protective Equipment (PPE) I Healthcare Settings 

PDF 285 KB (49 pages) 

Questions and Answers Regarding Respiratory Protection For Preventing 2009 H1N1 Influenza Among Healthcare 

Personnel 

Questions and Answers about CDC’s Interim Guidance on Infection Control Measures for 2009 H1N1 Influenza in 

Healthcare Settings Including Protection of healthcare Personnel 

Interim Guidance on Infection Control Measures for 2009 H1N1 Influenza in Healthcare Settings, Including Protection 

of Healthcare Personnel, Updated 10/14/09 

CDC Q&A: Regarding Respiratory Protection for Infection Control Measures for 2009 H1N1 Influenza among 

Healthcare Personnel 

NIOSH Statement: The Risk of Serious Illness Among Healthcare Personnel Associated with 2009 H1N1 Influenza 

Posters from CDC 

CDC Clean Hands Save Lives - Protect patients, protect yourself (poster) 

PDF 44 KB (1 page) 

CDC General Procedures for Properly Putting on and Taking Off a Disposable Respirator 

PDF 5.06 MB (1 page) En español 

OSHA 

Respiratory Protection for Healthcare Workers Training Video

Pandemic Influenza Preparedness and Response Guidance for Healthcare Workers and Healthcare Employers 

Frequently Asked Questions on Pandemic Influenza Preparedness and Response Guidance for Healthcare Workers 

and Healthcare Employers 

Preparing Workplaces for an Influenza Pandemic (2009) 

PDF 615 KB (46 pages) 

The Difference Between Respirators and Surgical Masks 

(Possible Solutions section) 

Respirator Safety 

(Training Video section) 

Workplace Safety and H1N1 

OSHA Quick Card: Protect Yourself Pandemic Flu Respiratory Protection 

OSHA Fact Sheet: Respiratory Infection Control: Respirators Versus Surgical Masks 

OSHA Safety and Health Topics: Respiratory Protection 

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