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510(k) Data Aggregation

    K Number
    K162626
    Device Name
    THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE
    Manufacturer
    TOP QUALITY GLOVE SDN. BHD
    Date Cleared
    2017-03-31

    (192 days)

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

    TOP QUALITY GLOVE SDN. BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Thermoplastic Polyethylene Examination (TPE) Glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner
    Device Description
    Not Found
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