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510(k) Data Aggregation

    K Number
    K151208
    Device Name
    Powder Free Nitrile Examination Glove
    Date Cleared
    2015-09-14

    (131 days)

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

    VRG KHAI HOAN JOINT STOCK COMPANY

    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
    POWDER FREE NITRILE EXAMINATION GLOVE
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