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510(k) Data Aggregation

    K Number
    K181106
    Device Name
    Powder Free Nitrile Patient Examination Gloves, Blue Color
    Manufacturer
    JiangSu DongXin Medical Technology Co., Ltd
    Date Cleared
    2019-01-16

    (265 days)

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

    JiangSu DongXin Medical Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.
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