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510(k) Data Aggregation

    K Number
    K131828
    Device Name
    POWDER FREE VINYL PATIENT EXAMINATION GLVOES, LIGHT YELLOW COLOR
    Date Cleared
    2013-11-26

    (159 days)

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

    JIANGSU HANDSAFE GLOVE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Powder Free Vinyl Patient Examination Gloves, Light Yellow Color is a 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
    PVC films form a barrier to body fluids and bloodborne Pathogens. The PVC rubber is water tight under normal conditions of use. Its tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Poly (viny) chloride) glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching process removes traces of chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.
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