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510(k) Data Aggregation

    K Number
    K211073
    Device Name
    Disposable Nitrile Examination Gloves
    Manufacturer
    Foshan Kangkang Biotechnology Co., LTD
    Date Cleared
    2021-09-21

    (162 days)

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

    Foshan Kangkang Biotechnology Co., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Disposable Nitrile Examination Gloves is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.
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