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510(k) Data Aggregation

    K Number
    K161072
    Device Name
    Powder Free Grey Vinyl Examination Gloves
    Date Cleared
    2016-07-14

    (87 days)

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

    ZIBO FLOURISH TRADING CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Powder Free Grey Vinyl Patient Examination Gloves is a 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 proposed device. Powder Free Grey Vinvl Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. The proposed is Powder Free Grey Vinyl Patient Examination Gloves, and includes variations of different size.
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