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

    MEDIGLOVES STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES

    K Number: K050181 · Decision Apr 13, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    6
    Review Days
    76

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    Basic Information

    Device Name
    MEDIGLOVES STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES
    K Number
    K050181
    Device Class
    FDA class 1
    Clearance Type
    Abbreviated
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medigloves , Ltd.
    Date Received
    January 27, 2005
    Decision Date
    April 13, 2005
    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 Medigloves , Ltd.

    K Number Device Name
    K930794 MEDIGLOVES, MEDPAC, BOSTON, FISHERBRAND, GLOVES
    K930795 MEDIGLOVES, FISHERBRAND, MEDIPRODUCTS GLOVES
    K912503 HYPOALLERGENIC EXAMINATION LATEX GLOVES
    K912157 HYPOALLERGENIC SURGICAL LATEX GLOVES
    K891326 PATIENT EXAMINATION GLOVES (LATEX)