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    K Number
    K063810
    Device Name
    YULEX LATEX POWDER-FREE EXAM GLOVES
    Manufacturer
    YULEX CORPORATION
    Date Cleared
    2008-04-18

    (483 days)

    Product Code
    OIG
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    YULEX CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A disposable device made from guayule natural rubber. The device may bear a trace amount of glove powder and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
    Device Description
    The device is described as a Class I powder-free patient examination glove, made from guayule natural rubber, which meets all of the requirements of ASTM standard D3578-05. A disposable device made from guayule natural rubber. The device may bear a trace amount of glove powder and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
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