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510(k) Data Aggregation

    K Number
    K180861
    Device Name
    Vinyl Examination Glove (Clear, Non-Colored)
    Manufacturer
    Zhicheng Trading Co., Ltd.
    Date Cleared
    2018-06-13

    (72 days)

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

    Zhicheng Trading Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vinyl Examination Glove (Clear, Non-Colored) 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 is Powder Free Vinyl Patient Examination Gloves. The colors of proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile.
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