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510(k) Data Aggregation

    K Number
    K211778
    Device Name
    Nitrile Examination Gloves, Green/ Blue/ Black Color
    Manufacturer
    Zhenjiang SuHui Latex Products Co., Ltd.
    Date Cleared
    2021-09-02

    (85 days)

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

    Zhenjiang SuHui Latex Products Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Nitrile Examination Gloves,Green/ Blue/ Black Color are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
    Device Description
    The subject device is powder free nitrile examination gloves. The subject device is provided in color Green, Blue or Black. The subject device is nonsterile.
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