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510(k) Data Aggregation

    K Number
    K981876
    Device Name
    SYNTHETIC EXAMINATION GLOVE, POWDERED
    Manufacturer
    HSING YI PLASTICS PROCESSING CO, LTD.
    Date Cleared
    1998-09-30

    (125 days)

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

    HSING YI PLASTICS PROCESSING CO, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination glove 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
    The device is powdered synthetic vinyl exam glove. They are nonsterile, single use, disposable gloves.
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