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510(k) Data Aggregation

    K Number
    K213371
    Device Name
    Disposable Medical Nitrile Examination Gloves (Model:XYS-001)
    Manufacturer
    Anhui Xinyisheng Medical Technology Co.,Ltd
    Date Cleared
    2021-12-09

    (58 days)

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

    Anhui Xinyisheng Medical Technology Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable Medical Nitrile Examination Gloves is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Disposable Medical Nitrile Examination Gloves (Model: XYS-001, Size Large) is a patient examination qlove and it is made from nitrile compound. It is a single-use, powder-free and nonsterile product. The glove is worn on the examiner's hand to prevent contamination between patient and examiner, and this device meets all the requirement specifications in the ASTM D6319-19 Standard.
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