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510(k) Data Aggregation

    K Number
    K100339
    Device Name
    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    TANGSHAN CHANGRONG GLOVE CO., LTD.
    Date Cleared
    2010-03-22

    (45 days)

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

    TANGSHAN CHANGRONG GLOVE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Powder free vinyl patient examination glove 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.
    Device Description
    powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.
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