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510(k) Data Aggregation

    K Number
    K222534
    Device Name
    Nitrile Patient Examination Glove
    Manufacturer
    Jiangxi Jiangxi Zhonghong Pulin Medical Products Co.,Ltd.
    Date Cleared
    2022-11-23

    (93 days)

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

    Jiangxi Jiangxi Zhonghong Pulin Medical Products Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nitrile Patient 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 blue. The subject device is non-sterile.
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