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510(k) Data Aggregation

    K Number
    K070519
    Device Name
    PRIME PROTECTION POWDERED VINYL EXAMINATION GLOVES
    Manufacturer
    ZHANGJIAGANG HUAYUAN PLASTIC CO., LTD.
    Date Cleared
    2007-04-10

    (47 days)

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

    ZHANGJIAGANG HUAYUAN PLASTIC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A powdered vinyl examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner.
    Device Description
    Not Found
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