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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
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


Premarket Reviews
ManufacturerDecision
INNONIX TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
NBC MESHTEC INC.
  SUBSTANTIALLY EQUIVALENT 1

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