BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BARRIERPLUS SYNTHETIC POWDER-FREE SURGICAL GLOVES

    K Number: K990710 · Decision May 20, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    5
    Review Days
    77

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    Basic Information

    Device Name
    BARRIERPLUS SYNTHETIC POWDER-FREE SURGICAL GLOVES
    K Number
    K990710
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Barriermed Glove Co.
    Date Received
    March 4, 1999
    Decision Date
    May 20, 1999
    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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    Other Clearances by Barriermed Glove Co.

    K Number Device Name
    K053406 BARRIERPLUS GOLD POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES
    K061038 BARRIERPLUS PLATINUM POWDER-FREE SYNTHETIC POLYCHLOROPRENE SURGICAL GLOVES, MODELS 12544-125490
    K052772 BARRIERPLUS GOLD ORTHO POWDER-FREE SYNTHETIC POLYISOPRENE ORTHOPEDIC SURGICAL GLOVES
    K052892 SYNTHALON PC PLUS POWDER-FREE POLYCHLOROPRENE EXAMINATION GLOVES, MODELS 1372-11 TO 1272-55