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510(k) Data Aggregation

    K Number
    K182640
    Device Name
    Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue)
    Manufacturer
    Shandong Hengya Packaging Printing Co.,Ltd
    Date Cleared
    2019-04-12

    (200 days)

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

    Shandong Hengya Packaging Printing Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Powder Free Nitrile Examination Gloves(White, Cobalt Blue) 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 Nitrile Examination Gloves(White, Cobalt Blue, Blue and Violet Blue)
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