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510(k) Data Aggregation

    K Number
    K210106
    Device Name
    Nitrile Examination Gloves
    Manufacturer
    Zhenjiang Huayang Latex Products Co., Ltd.
    Date Cleared
    2021-04-07

    (82 days)

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

    Zhenjiang Huayang Latex Products Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Nitrile Examination Gloves is a disposable device intended for medical purposes that is 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 blue. The subject device is non-sterile.
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