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510(k) Data Aggregation

    K Number
    K102613
    Device Name
    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    HEBEI FAVOR PLASTIC CO., LTD
    Date Cleared
    2011-01-13

    (125 days)

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

    HEBEI FAVOR PLASTIC CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Powder free vinyl patient examination glove is non-sterile ,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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