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510(k) Data Aggregation

    K Number
    K202402
    Device Name
    Nitrile Examination Gloves (Blue, Violet Blue, White)
    Date Cleared
    2021-03-01

    (192 days)

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

    Jiangsu Tianshuo Medical Products Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NITRILE EXAMINATION GLOVES (Blue, Violet Blue, \Vhite) 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 GLOVES (Blue, Violet Blue, White) 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 NITRILE EXAMINATION GLOVES (Blue, Violet Blue, White) includes variations of different size and color. The colors of the proposed device are Blue, and White.
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