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510(k) Data Aggregation

    K Number
    K172357
    Device Name
    Disposable Powder Free Vinyl Exam Glove, Clear/Yellow
    Date Cleared
    2017-12-29

    (148 days)

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

    EVER GROWTH (VIETNAM) CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
    Device Description
    Disposable Powder Free Vinyl Exam Glove, Clear/ Yellow
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