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510(k) Data Aggregation

    K Number
    K223250
    Device Name
    Disposable Nitrile Examination Glove
    Manufacturer
    Yangzhou Saraguard Medical Supplies Co.,Ltd.
    Date Cleared
    2023-01-19

    (90 days)

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

    Yangzhou Saraguard Medical Supplies Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The disposable nitrile medical examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
    Device Description
    The subject device is powder free nitrile examination gloves. The subject device is available in color blue and white, and it provides five specifications: XS,S, M, L, and XL. The subject device is non-sterile.
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