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510(k) Data Aggregation

    K Number
    K203666
    Device Name
    Vinyl Examination Gloves(Yellow)
    Manufacturer
    Lutai Medical Technology Co.,LTD.
    Date Cleared
    2021-03-12

    (86 days)

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

    Lutai Medical Technology Co.,LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vinyl Examination Gloves(Yellow) 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 subject device is powder free vinyl patient examination gloves. The subject device is yellow. 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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