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510(k) Data Aggregation

    K Number
    K212029
    Device Name
    Disposable Medical Nitrile Examination Gloves (non-sterile)
    Manufacturer
    Taizhou Kangjian Medical Equipments Co., Ltd.
    Date Cleared
    2021-11-16

    (140 days)

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

    Taizhou Kangjian Medical Equipments Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable Medical Nitrile Examination Glove is 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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