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510(k) Data Aggregation

    K Number
    K212497
    Device Name
    Nitrile Examination Glove (Powder free, Blue)
    Date Cleared
    2021-11-11

    (94 days)

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

    Jiangsu Jinlian Medical Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Nitrile Examination Glove (Powder free, Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
    Device Description
    The proposed device, Nitrile Examination Glove (Powder free, Blue) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size. The color of the proposed device is Blue. The proposed device is not provided as sterilized The proposed device is made of Nitrile.
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