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

    SYNTHETIC POWDER FREE (PINK) VINYL PATIENT EXAMINATION GLOVE

    K Number: K082029 · Decision Sep 26, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    795
    Applicant Total
    11
    Review Days
    71

    Basic Information

    Device Name
    SYNTHETIC POWDER FREE (PINK) VINYL PATIENT EXAMINATION GLOVE
    K Number
    K082029
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    EVER LIGHT PLASTIC PRODUCTS CO., LTD.
    Date Received
    July 17, 2008
    Decision Date
    September 26, 2008
    Product Code
    LYZ
    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
    LYZ Vinyl Patient Examination Glove

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    Other Clearances by EVER LIGHT PLASTIC PRODUCTS CO., LTD.

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