FDA 510K? Is it necessary?
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FDA 510K? Is it necessary?

Views: 0     Author: Site Editor     Publish Time: 2021-07-20      Origin: Site

Medical Mask

The US regulatory agency for medical masks is the FDA. There are three classification codes for masks in the FDA system: FXX, OUK & ORW. They all belong to rule 878.4040, and they all need to apply for FDA 510K approval. Since the product code ORW is used for N95 respirators, the products listed under this code must be NIOSH certified before they can be imported.

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Non-Medical Mask

Products that are not intended for a medical purpose such as preventing transmission of infection through respiratory secretions, and that are labeled only for general purposes such as industrial use -- may be imported without FDA.



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