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510(k) Data Aggregation

    K Number
    K211914
    Device Name
    Nitrile Patient Examination Gloves
    Manufacturer
    Yingxiang Glove Products Co., Ltd.
    Date Cleared
    2021-10-14

    (115 days)

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

    Yingxiang Glove Products Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nitrile 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 proposed device is Powder Free Nitrile Patient Examination 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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