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Sep 30, 2020 · The FDA designation as a Surgical N95 requires both NIOSH N95 certification as well as FDA 510K clearance as a Surgical Mask. The clearance of a NIOSH approved N95 as a Surgical N95 by the FDA requires fluid penetration tests along with other criteria. The list of Surgical N95 as provided by the NPPTL/NIOSH may be found here (CDC.gov Link).

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