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510(k) Data Aggregation

    K Number
    K211239
    Device Name
    Vinyl Patient Examination Gloves
    Manufacturer
    Jiangxi Shengda Medical Technology Co., Ltd.
    Date Cleared
    2021-07-17

    (82 days)

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

    Jiangxi Shengda Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Vinyl Patient Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
    Device Description
    The subject device is powder free vinyl patient examination gloves. The subject device is clear. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is nonsterile.
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