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Understanding the Difference
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
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
Fit Testing Requirement
User Seal Check Requirement
Yes. Required each time the respirator is donned (put on)
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 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
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.
Centers for Disease Control and Prevention
National Institute for Occupational Safety and Health
CDA APPROVED SURGICAL MASK FOR SALE
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