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510(k) Data Aggregation

    K Number
    K170393
    Device Name
    Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue)
    Manufacturer
    Zibo Chengxun Automatic Device Co., Ltd
    Date Cleared
    2017-05-09

    (90 days)

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

    Zibo Chengxun Automatic Device Co., Ltd

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