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510(k) Data Aggregation

    K Number
    K210058
    Device Name
    Blue Nitrile Exam Glove, Powder Free
    Manufacturer
    Great Harvest Trading Co., Ltd.
    Date Cleared
    2021-03-30

    (78 days)

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

    Great Harvest Trading Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Blue Nitrile Exam Glove, Powder Free 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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