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510(k) Data Aggregation

    K Number
    K973664
    Device Name
    LATEX EXAM GLOVE, POWDER-FREE W/PROTEIN & HYPOALLERGENIC LABELING
    Manufacturer
    EVERGRADE HEALTHCARE PRODUCTS SDN BHD
    Date Cleared
    1998-03-13

    (169 days)

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

    EVERGRADE HEALTHCARE PRODUCTS 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 hand or finger to prevent contamination between patient and examiner.
    Device Description
    Latex Exam Glove, Powder Free with Protein and Hypoallergenic Labeling. 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.
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