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510(k) Data Aggregation

    K Number
    K211581
    Device Name
    Disposable Nitrile Examination Gloves (Powder free, Blue)
    Date Cleared
    2021-10-28

    (160 days)

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

    Leping Shengde Medical Technology Company Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DISPOSABLE NITRILE EXAMINATION GLOVES (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, DISPOSABLE NITRILE EXAMINATION GLOVES (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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