Understanding the Difference

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Surgical Mask N95 Respirator

Elastomeric Half 

Facepiece Respirator

Testing and 

Approval

Cleared by the U.S. Food and 

Drug Administration (FDA)

Evaluated, tested, and 

approved by NIOSH as per the 

requirements in 

42 CFR Part 84*

Evaluated, tested, and 

approved by NIOSH as per the 

requirements in 

42 CFR Part 84

Intended Use and 

Purpose

Fluid resistant and provides the 

wearer protection against large 

droplets, splashes, or sprays of 

bodily or other hazardous fluids. 

Protects the patient from the 

wearer’s respiratory emissions.

Reduces wearer’s exposure to 

particles including small particle 

aerosols and large droplets (only 

non-oil aerosols)

Reusable device made of 

synthetic or rubber material

Face Seal Fit Loose-fitting Tight-fitting Tight-fitting

Fit Testing 

Requirement

No Yes Yes

Designed for 

Reuse

No No Yes

User Seal Check No Yes. Required each time the 

respirator is donned (put on)

Yes. Required each time the 

respirator is donned (put on)

Filtration Does NOT provide the wearer 

with a reliable level of protection 

from inhaling smaller airborne 

particles and is not considered 

respiratory protection

Filters out at least 95% of 

airborne particles including large 

and small particles

May be equipped with filters 

that block 95%, 99%, or 100% 

of very small particulates. Also 

may be equipped to protect 

against vapors/gases.

Leakage Leakage occurs around the edge 

of the mask when user inhales

When properly fitted and 

donned, minimal leakage occurs 

around edges of the respirator 

when user inhales

When properly fitted and 

donned, minimal leakage occurs 

around edges of the respirator 

when user inhales

Use Limitations Disposable. Discard after each 

patient encounter.

Ideally should be discarded after 

each patient encounter and after 

aerosol-generating procedures. 

It should also be discarded 

when it becomes damaged 

or deformed; no longer forms 

an effective seal to the face; 

becomes wet or visibly dirty; 

breathing becomes difficult; 

or if it becomes contaminated 

with blood, respiratory or nasal 

secretions, or other bodily fluids.

Reusable and must be cleaned/

disinfected and stored between 

each patient interaction

*As of July 2, 2018, NIOSH evaluates N95 FFRs intended for use in healthcare for biocompatibility, flammability, and fluid resistance to ensure conformity to relevant standards during the 

approval process. These tasks were previously performed by the FDA.

Resources: 

Hospital Respiratory Protection Program Toolkit, http://www.cdc.gov/niosh/docs/2015-117/pdfs/2015-117.pdf

Implementing Hospital Respiratory Protection Programs: Strategies from the Field, https://www.jointcommission.org/assets/1/18/Implementing_Hospital_RPP_2-19-15.pdf

This information provides clarification regarding respirator and 

mask use in workplaces in which employees are exposed to 

respiratory hazards, it is not specific for the COVID-19 pandemic.

Centers for Disease Control

and Prevention

National Institute for Occupational 

Safety and Health