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

    LATEX EXAMINATION GLOVES POWDER FREE

    K Number: K982579 · Decision Aug 11, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    5
    Review Days
    18

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    Basic Information

    Device Name
    LATEX EXAMINATION GLOVES POWDER FREE
    K Number
    K982579
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shiva Medicare , Ltd.
    Date Received
    July 24, 1998
    Decision Date
    August 11, 1998
    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 Shiva Medicare , Ltd.

    K Number Device Name
    K984615 POWDERED NITRILE EXAMINATION GLOVES
    K984610 POWDER FREE NITRILE EXAMINATION GLOVES
    K982589 SURGEON'S GLOVE
    K982586 POWDER FREE SURGEONS GLOVE