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510(k) Data Aggregation

    K Number
    K110016
    Device Name
    POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
    Manufacturer
    RONGYAO PLASTIC PRODUCE CO., LTD
    Date Cleared
    2011-08-23

    (232 days)

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

    RONGYAO PLASTIC PRODUCE CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Powder Free Vinyl Patient Examination Gloves, Colored (Yellow) 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, Colored (Yellow) are disposable devices which made of poly(vinyl chloride) polymer compound, intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between pattent and examiner and they meets all of the requirements of ASTM standard D 5250-06 el .
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