BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇳 India

    SURGICAL RUBBER GLOVES

    K Number: K911268 · Decision Jun 13, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    556
    Applicant Total
    2
    Review Days
    83

    Basic Information

    Device Name
    SURGICAL RUBBER GLOVES
    K Number
    K911268
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    PACIFICLINK EXPORT
    Date Received
    March 22, 1991
    Decision Date
    June 13, 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 PACIFICLINK EXPORT

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