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

    SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES

    K Number: K023236 · Decision Nov 12, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    26
    Review Days
    46

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    Basic Information

    Device Name
    SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES
    K Number
    K023236
    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
    Maxxim Medical
    Date Received
    September 27, 2002
    Decision Date
    November 12, 2002
    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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