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510(k) Data Aggregation

    K Number
    K212921
    Device Name
    Nitrile Examination Golves Powder Free
    Manufacturer
    Jiangsu Standard Health Co.,Ltd
    Date Cleared
    2021-12-24

    (101 days)

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

    Jiangsu Standard Health Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Nitrile Examination Golves Powder Free is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
    Device Description
    The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
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