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510(k) Data Aggregation

    K Number
    K153159
    Device Name
    Vinyl patient examination glove, Powder Free
    Date Cleared
    2016-01-26

    (85 days)

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

    XINGYUAN PLASTIC PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Vinyl patient examination glove, Powder Free, 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, Vinyl patient examination glove, Powder Free 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 Vinyl Patient Examination Gloves without color, and includes variations of different size.
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