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510(k) Data Aggregation

    K Number
    K151528
    Device Name
    Powder Free Nitrile (Black) Examination Gloves
    Manufacturer
    GALLANT QUALITY SDN. BHD.
    Date Cleared
    2015-10-09

    (123 days)

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

    GALLANT QUALITY SDN. BHD.

    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 hands or fingers to prevent contamination between patient and examiner.
    Device Description
    The Powder Free Nitrile (Black) Examination Gloves meets all the requirements of ASTM Specification D6319-10 -Standard Specification for Nitrile Examination Gloves for Medical Application.
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