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510(k) Data Aggregation

    K Number
    K173228
    Device Name
    U-MED Powder Free Polyethylene Examination Gloves,Blue Color
    Date Cleared
    2018-02-20

    (139 days)

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

    **Jiangsu U-MED Rubber **& Plastic Products Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Powder Free Polyethylene Examination Gloves,Blue 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
    The U-MED Powder Free Polyethylene Examination Gloves,Blue Color are nonsterile disposable Patient examination glove. The gloves are made of translucent (clear), Low Density Polyethylene material and are powder free. The U-MED Powder Free Polyethylene Examination Gloves,Blue Color come in four sizes: Small, Medium, Large, X Large. The Powder Free Polyethylene Examination Gloves, Blue Color acts as a barrier to prevent contamination between patient and examiner. The physical and performance characteristics of the devices meets all requirements of ASTM D5250 and ASTM D5151.
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