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510(k) Data Aggregation

    K Number
    K111598
    Device Name
    POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVE
    Manufacturer
    LPL (HUI ZHOU) GLOVE CO., LTD.
    Date Cleared
    2011-07-20

    (42 days)

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

    LPL (HUI ZHOU) GLOVE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The powder free vinyl patient examination glove (non-sterile) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. It is sold as non-sterile.
    Device Description
    Powder Free Vinyl Patient Examination Gloves (Non-Sterile), that meets all of the requirement of ASTM standard D 5250-06, except for sterility requirements.
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