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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device n95 respirator with antimicrobial/antiviral agent
Regulation Description Surgical apparel.
Definition A single use, disposable, NIOSH-approved respirator intended for occupational use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological particulates and has an added antimicrobial and/or antiviral agent which kills specified pathogens under specified contact conditions.
Product CodeONT
Regulation Number 878.4040
Device Class 2

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