Testing and Approval

Cleared by the U.S. Food and Drug Administration (FDA)

N95 Respirator

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).

Face Seal Fit

Loose-fitting

Tight-fitting

Fit Testing Requirement

No

Yes

User Seal Check Requirement

No

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

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

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 from patients.