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510(k) Data Aggregation

    K Number
    K223221
    Device Name
    Non-Sterile Powder Free Nitrile Examination Gloves
    Manufacturer
    Dynacare Sdn Bhd
    Date Cleared
    2023-01-13

    (88 days)

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

    Dynacare 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
    Non-Sterile Powder Free Nitrile Examination Gloves
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