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510(k) Data Aggregation

    K Number
    K161085
    Device Name
    Nitrile Patient Examination Powder Free Glove, Textured, Black
    Manufacturer
    MULTISAFE SDN. BHD.
    Date Cleared
    2018-07-05

    (808 days)

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

    MULTISAFE 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
    Nitrile Patient Examination Powder Free Glove, Textured, Black
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