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510(k) Data Aggregation

    K Number
    K981942
    Device Name
    LATEX POWDER FREE EXAMINATION GLOVES
    Date Cleared
    1998-12-14

    (195 days)

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

    MAIKA RUBBER PRODUCTS SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A Latex Powder Free examination glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient
    Device Description
    Latex Powder-Free Examination Gloves
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