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510(k) Data Aggregation

    K Number
    K211341
    Device Name
    Blue Nitrile Exam Gloves
    Manufacturer
    Jiangxi Surefine Medical Co., Ltd.
    Date Cleared
    2021-07-29

    (87 days)

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

    Jiangxi Surefine Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Blue Nitrile Exam 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 proposed device is Powder Free Blue Nitrile Exam Gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The proposed device is non-sterile.
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