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510(k) Data Aggregation

    K Number
    K982691
    Device Name
    MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
    Date Cleared
    1998-10-09

    (67 days)

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

    PERUSAHAAN INTAN EMAS SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Latex Examination Glove is a disposable medical device intended for medical handling purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the blood, other body fluids, mucous membranes, or non-intact skin of patient.
    Device Description
    Not Found
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