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List of Face Mask Manufacturers in China: Our Top 7 Picks 4-ply and 5-ply masks also contain an activated carbon filter and/or an additional filtering layer. Thus, they offer extra protection. United States. In the US, surgical masks are classified as Class II medical devices by the FDA and are regulated under 21 CFR Section 878.4040. There exist several ASTM standards that define fluid ...

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