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510(k) Data Aggregation

    K Number
    K213681
    Device Name
    Ivory Glove Powder-Free Nitrile Examination Gloves
    Manufacturer
    Ivory Gloves SDN. BHD.
    Date Cleared
    2022-04-21

    (150 days)

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

    Ivory Gloves SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A single use disposable device intended for medical purposes that is worn on the hands of examiners to prevent contamination between the examiner and the patient.
    Device Description
    Not Found
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