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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State The device is a surgical mask composed of at least 3 layers of filtration material with bands or ties to secure it to the head, a flexible noseband and an added, specified antimicrobial and/or antiviral agent added to the surgical mask
Technical Method Device uses a combination multiple filtration layers to protect from the transfer of microorganisms, body fluids and particulates plus the addition of an antimicrobial and/or antiviral agent which kills specified pathogensunder specified contact conditions
Target Area The device is worn over the nose and mouth and is intended to protect the respiratory tract from transfer of microorganisms, body fluids and particulates.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General Hospital
Product CodeOUK
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
Submission Type 510(k)
Regulation Number 878.4040
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible