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510(k) Data Aggregation

    K Number
    K211667
    Device Name
    Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)
    Manufacturer
    Changzhou Universal Medical Equipment Co. Ltd
    Date Cleared
    2021-09-23

    (114 days)

    Product Code
    LAZ, LZA
    Regulation Number
    862.3280
    Why did this record match?
    Product Code :

    LAZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable Medical Synthetic Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    The subject device in this 510(k) Notification is Disposable Medical Synthetic Nitrile Examination Gloves. Non-sterile. The subject device is a patient examination glove made from nittile and vinyl compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
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