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510(k) Data Aggregation

    K Number
    K143340
    Device Name
    Powder Free Vinyl Patient Examination Gloves, Yellow Color
    Date Cleared
    2015-07-09

    (230 days)

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

    Zibo Ling Yun 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 fingers to prevent contamination between patient and examiner.
    Device Description
    Powder-free Vinyl Patient Examination Gloves, Yellow Color. A disposable device intended for medical purposes that is worn upon the examiner's hands or finger. Prevent contamination between patient and examiner. Cover the hand and wrist area. Covers have separate sheaths or openings for each finger and the thumb.
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