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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device surgical mask with antimicrobial/antiviral agent
Regulation Description Surgical apparel.
Definition A single use, disposable surgical mask for occupational use to cover the nose and mouth of the wearer to protect from the transfer of microorganisms,body fluids and particulates and has an added antimicrobial and/or antiviral agent which kills specific pathogens under specified contact conditions.
Product CodeOUK
Regulation Number 878.4040
Device Class 2