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510(k) Data Aggregation

    K Number
    K171317
    Device Name
    Clear Vinyl Powder-free Patient Examination Gloves
    Date Cleared
    2017-09-11

    (130 days)

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

    Shandong Zhi Hong Medical Products, Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination glove is a 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 devices, Powder-free Vinyl Exam Gloves are non-sterile, clear, noncolored and disposable medical gloves intended to be worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
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