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COVID-19 FDA Exemptions Due to Mask Shortages in the United States. Due to the current situation, the FDA is currently accepting the import N95 respirators that aren’t approved by NIOSH, but which are approved by authorities in the EU, China, Japan, Korea, Mexico, Australia, or Brazil.

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The highest level of certification would be a medical device labeled mask with a 510k number. If the mask is not used for surgical use and carries a splash rating then the mask may still have a medical designation with a listing number. You can always look up any medical distributorship or medical company in the FDA establishment listing database.

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particular medical face mask material does not ensure that the wearer will be protected from biological aerosols, since this test method primarily evaluates the performance of the composite materials used in the construction of the medical face mask and not its design, fit, or facial-sealing properties.

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