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510(k) Data Aggregation

    K Number
    K984229
    Device Name
    LATEX EXAMINATION GLOVES (POWDERED)
    Date Cleared
    1999-05-17

    (173 days)

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

    SAMA KEJURUTERAAN SDN.BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Latex Examination Glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
    Device Description
    Latex Examination Gloves (Powdered)
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