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A surgical mask serves as a mechanical barrier that interferes with direct airflow in and out of respiratory orifices (i.e. nose and mouth).Most commonly used surgical masks are designed to only trap respiratory droplets, and therefore do not filter or block fine airborne particles that are smaller than the designed filtration ratings, which may be transmitted by coughs, sneezes, unintentional ...
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The NIOSH-provided classifications only cover the filtration of particles or aerosols, not the air-purifying respirator's ability to remove chemical gasses and vapors from air, which is regulated under 42 CFR 84 Subpart L. For chemical cartridge classifications, NIOSH, under 42 CFR 84, partially defers to American National Standard ANSI K13.1-1973.
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A surgical mask is a loosely-placed, unsealed barrier, meant to stop droplets, and other liquid-borne particles from the mouth and nose that may contain pathogens. [50] A surgical mask may not block all particles, due to the lack of fit between the surface of the face mask and the face. [50]
[64] 510(K) is a premarket submission made to the Food and Drug Administration in order to demonstrate that the device to be sold is safe and effective. Surgical and surgical isolation gowns are regulated by the FDA as Class II medical devices that require a 510(k). Non-surgical gowns are class I medical devices that do not need a 510(k) clearance.
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