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There are currently no FDA-approved face masks, surgical masks, or respirators. To identify FDA-cleared face masks, surgical masks, and respirators, search the 510(k) Premarket Notification database .

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A medical mask is defined by its ability to resist fluid splatter. Only a few N95 masks are actually considered to be medical grade, such as the 3M 1869 masks. Due to a shortage of medical N95 masks during the COVID 19 pandemic, the FDA released an approved list of KN95 masks to be used in emergency medical settings.

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