BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇹🇭 Thailand

    Sterile Latex Powder Free Surgical Gloves

    K Number: K253060 · Decision May 22, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    1
    Review Days
    242

    Basic Information

    Device Name
    Sterile Latex Powder Free Surgical Gloves
    K Number
    K253060
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Protect Gloves Company Limited
    Date Received
    September 22, 2025
    Decision Date
    May 22, 2026
    Product Code
    KGO
    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
    KGO Surgeon'S Gloves

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