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510(k) Data Aggregation

    K Number
    K110945
    Device Name
    POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    ZHAOYANG PLASTIC CO., LTD
    Date Cleared
    2011-09-13

    (162 days)

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

    ZHAOYANG PLASTIC CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Powder-free yellow synthetic vinyl patient examination gloves 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 yellow synthetic vinyl patient examination gloves that meets all of the requirements of ASTM standard D 5250-06.
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