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510(k) Data Aggregation

    K Number
    K221877
    Device Name
    Powder-Free Nitrile Examination Glove, Non-Sterile
    Date Cleared
    2022-07-23

    (25 days)

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

    GoodGloves Industries Sdn Bhd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Powder-Free Nitrile Examination Gloves, Non-Sterile (Blue) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    The Powder-Free Nitrile Examination Gloves, Non-Sterile (Blue) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The device is for over-the-counter use and single use only. The Powder-Free Nitrile Examination Gloves, Non-Sterile (Blue) is made of Nitrile, a synthetic rubber copolymer of acrylonitrile and butadiene. The device does not incorporate powder for purpose other than manufacturing. The final finished glove includes only residual powder from manufacturing. The Powder-Free Nitrile Examination Gloves, Non-Sterile is finishing through polymer coating process. The device is provided non-sterile.
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