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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 for use by the general public in public health medical emergencies
Regulation Description Filtering facepiece respirator for use by the general public in public health medical emergencies.
Definition A single use, disposable, NIOSH-approved N95 respirator intended for use by the general public in public health medical emergencies 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 CodeORW
Regulation Number 880.6260
Device Class 2

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