BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇲🇾 Malaysia

    POWDERED LATEX STERILE SURGICAL GLOVES

    K Number: K992219 · Decision Jul 30, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    9
    Review Days
    29

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    Basic Information

    Device Name
    POWDERED LATEX STERILE SURGICAL GLOVES
    K Number
    K992219
    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
    Tg Medical Sdn. Bhd.
    Date Received
    July 1, 1999
    Decision Date
    July 30, 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 Tg Medical Sdn. Bhd.

    K Number Device Name
    K171276 Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs
    K113393 POWDER FREE BLACK NITRILE EXAMINATION GLOVES
    K993562 POWDER FREE LATEX STERILE SURGICAL GLOVES
    K992841 TG MEDICAL POWDERED NITRILE BLUE EXAMINATION GLOVES
    K992360 TG MEDICAL POWDERED NITRILE EXAMINATION GLOVES
    K990668 POWDER FREE BLUE NITRILE GLOVE
    K982872 TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
    K941900 POWDERED LATEX EXAM GLOVES