Understanding the Difference

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Elastomeric Half
Surgical Mask N95 Respirator Facepiece Respirator

Testing and Cleared by the U.S. Food and Evaluated, tested, and Evaluated, tested, and
Approval Drug Administration (FDA) approved by NIOSH as per the approved by NIOSH as per the
requirements in requirements in
42 CFR Part 84* 42 CFR Part 84

Intended Use and Fluid resistant and provides the Reduces wearer’s exposure to Reusable device made of
Purpose wearer protection against large particles including small particle synthetic or rubber material
droplets, splashes, or sprays of aerosols and large droplets (only
bodily or other hazardous fluids. non-oil aerosols)
Protects the patient from the
wearer’s respiratory emissions.

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

Fit Testing No Yes Yes

Requirement

Designed for No No Yes

Reuse

User Seal Check No Yes. Required each time the Yes. Required each time the
respirator is donned (put on) respirator is donned (put on)

Filtration Does NOT provide the wearer Filters out at least 95% of May be equipped with filters
with a reliable level of protection airborne particles including large that block 95%, 99%, or 100%
from inhaling smaller airborne and small particles of very small particulates. Also
particles and is not considered may be equipped to protect
respiratory protection against vapors/gases.

Leakage Leakage occurs around the edge When properly fitted and When properly fitted and
of the mask when user inhales donned, minimal leakage occurs donned, minimal leakage occurs
around edges of the respirator around edges of the respirator
when user inhales when user inhales

Use Limitations
Disposable. Discard after each Ideally should be discarded after Reusable and must be cleaned/
patient encounter. each patient encounter and after disinfected and stored between
aerosol-generating procedures. each patient interaction
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.
*
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:
Centers for Disease Control Hospital Respiratory Protection Program Toolkit
and Prevention http://www.cdc.gov/niosh/docs/2015-117/pdfs/2015-117.pdf
National Institute for Occupational Implementing Hospital Respiratory Protection Programs: Strategies from the Field
Safety and Health
https://www.jointcommission.org/assets/1/18/Implementing_Hospital_RPP_2-19-15.pdf