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510(k) Data Aggregation

    K Number
    K213981
    Device Name
    Nitrile Examination Gloves
    Manufacturer
    Emerald Glove Manufacturing Sdn Bhd
    Date Cleared
    2022-11-12

    (327 days)

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

    Emerald Glove Manufacturing Sdn Bhd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    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
    Nitrile Examination Gloves
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