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510(k) Data Aggregation

    K Number
    K980071
    Device Name
    SUPERGLOVES LOW PROTEIN POWDER FREE LATEX EXAMINATION GLOVES
    Manufacturer
    SUPERMAX LATEX PRODUCTS SDN. BHD.
    Date Cleared
    1998-03-13

    (64 days)

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

    SUPERMAX LATEX PRODUCTS SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    Powder Free Latex Examination Gloves with Protein Content Labeling Claim (50 micrograms or less)
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