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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 arent approved by NIOSH, but which are approved by authorities in the EU, China, Japan, Korea, Mexico, Australia, or Brazil.

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Both the Medical Device Directive (93/42 / EEC) and the Medical Device Regulation (EU) 2017/745 specify the information that should appear on the packaging in which the medical face mask is supplied. The following information must be provideda) number of this European Standard; b) Type of mask (according to the information in the table).

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2016 11 22 · N95 mask, letter N for the United States standard, the number 95 is the protection level, mask filter material to particulate filtration efficiency of 95%. FFP3FFP3 mask, the letter FFP represents the European standard, letter 3 is the protection level, the European standard mask is divided into FFP1, FFP2, FFP3, FFP2 mask is equivalent to

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