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

    POWDER FREE LATEX EXAMINATION GLOVES

    K Number: K983998 · Decision Jan 21, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    6
    Review Days
    73

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    Basic Information

    Device Name
    POWDER FREE LATEX EXAMINATION GLOVES
    K Number
    K983998
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sri Anusham Rubber Industries Pvt., Ltd.
    Date Received
    November 9, 1998
    Decision Date
    January 21, 1999
    Product Code
    LYY
    Advisory Committee
    General Hospital
    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
    LYY Latex Patient Examination Glove

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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
    K984395 SURGEON'S GLOVES
    K915872 LATEX PATIENT EXAMINATION GLOVES