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510(k) Data Aggregation

    K Number
    K132221
    Device Name
    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
    Date Cleared
    2014-01-31

    (198 days)

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

    SHANDONG HAOYU 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 upon the examiner`s hands or finger to prevent contamination between patient and examiner.
    Device Description
    A Powder-Free Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner.
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