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510(k) Data Aggregation

    K Number
    K122920
    Device Name
    POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
    Manufacturer
    HEBEI LEADER PLASTIC CO., LTD
    Date Cleared
    2012-11-30

    (67 days)

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

    HEBEI LEADER PLASTIC CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
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