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

    COLOURED POWDWR-FREE SURGICAL GLOVES

    K Number: K980412 · Decision Apr 8, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    5
    Review Days
    64

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    Basic Information

    Device Name
    COLOURED POWDWR-FREE SURGICAL GLOVES
    K Number
    K980412
    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
    Kenwell International , Ltd.
    Date Received
    February 3, 1998
    Decision Date
    April 8, 1998
    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 Kenwell International , Ltd.

    K Number Device Name
    K980803 STERILE POWDER-FREE LATEX EXAMINATION GLOVES
    K963020 GLOVEL GX
    K911134 SURGICAL GLOVES
    K900811 LATEX PATIENT EXAMINATION GLOVES