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

    SURGEON'S GLOVES

    K Number: K984395 · Decision May 21, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    6
    Review Days
    164

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    Basic Information

    Device Name
    SURGEON'S GLOVES
    K Number
    K984395
    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
    Sri Anusham Rubber Industries Pvt., Ltd.
    Date Received
    December 8, 1998
    Decision Date
    May 21, 1999
    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 Sri Anusham Rubber Industries Pvt., Ltd.

    K Number Device Name
    K993349 NIL, SURGEON'S GLOVE - POWDER FREE
    K993348 NIL, NITRILE EXAMINATION GLOVE - POWDER FREE
    K993347 NIL, NITRILE EXAMINATION GLOVE - POWDERED
    K983998 POWDER FREE LATEX EXAMINATION GLOVES
    K915872 LATEX PATIENT EXAMINATION GLOVES