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510(k) Data Aggregation

    K Number
    K093759
    Device Name
    MULTIPLE NAME MODEL MULTIPLE
    Manufacturer
    GX CORPORATION SDN BHD (PLANT 1)
    Date Cleared
    2010-02-19

    (74 days)

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

    GX CORPORATION SDN BHD (PLANT 1)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Powder Free Nitrile Examination Gloves, Bubble Gum Scented, Blue
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