BEUDAMED
    Product Code: OUK FDA class 2 21 CFR 878.4040

    Surgical Mask With Antimicrobial/Antiviral Agent

    General, Plastic Surgery

    The Surgical Mask with Antimicrobial/Antiviral Agent (product code OUK) is a single-use disposable surgical mask for occupational use that covers the nose and mouth to protect against the transfer of microorganisms, body fluids, and particulates. In addition to standard barrier protection, it incorporates an antimicrobial and/or antiviral agent that kills specific pathogens under specified contact conditions. As an FDA Class 2 device under regulation 878.4040, it requires 510(k) premarket clearance and falls within the General and Plastic Surgery specialty, reviewed by the General Hospital panel. The device is not an implant and is not life-sustaining.

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    510(k)s
    4
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    4
    Years Active
    13

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    Basic Information

    Product Code
    OUK
    Device Class
    FDA class 2
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    HO
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    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.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 4 510(k) clearances via K numbers.

    K Number Device Name
    K231741 ProGear® Surgical Mask with Oxafence®, Model AV82030
    K192105 Innonix Antiviral Child's Face Mask
    K182766 Cufitec Surgical Mask
    K101128 BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.