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

    SURGICAL GLOVES

    K Number: K910895 · Decision Jul 22, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    5
    Review Days
    140

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    Basic Information

    Device Name
    SURGICAL GLOVES
    K Number
    K910895
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Influx Pacific Sdn. Bhd.
    Date Received
    March 4, 1991
    Decision Date
    July 22, 1991
    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 Influx Pacific Sdn. Bhd.

    K Number Device Name
    K980511 NITRILE EXAMINATION GLOVES - POWDER FREE
    K970216 NITRILE EXAMINATION GLOVES-PRE POWDERED
    K930407 POWDER-FREE LATEX EXAMINATION GLOVES
    K891668 PATIENT EXAMINATION GLOVES (LATEX)