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510(k) Data Aggregation

    K Number
    K211699
    Device Name
    Nitrile Exam Gloves, Powder Free, Blue
    Manufacturer
    Hengchang (Dongying) Medical Technology Co.,Ltd.
    Date Cleared
    2021-08-20

    (78 days)

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

    Hengchang (Dongying) Medical Technology Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Nitrile Exam Gloves, Powder Free, Blue are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
    Device Description
    Nitrile Exam Gloves, Powder Free, Blue
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