BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ProGear® Surgical Mask with Oxafence®, Model AV82030

    K Number: K231741 · Decision Sep 5, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    5
    Review Days
    449

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    Basic Information

    Device Name
    ProGear® Surgical Mask with Oxafence®, Model AV82030
    K Number
    K231741
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Prestige Ameritech
    Date Received
    June 14, 2023
    Decision Date
    September 5, 2024
    Product Code
    OUK
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OUK Surgical Mask With Antimicrobial/Antiviral Agent

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