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510(k) Data Aggregation

    K Number
    K162259
    Device Name
    DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
    Manufacturer
    ZIBO DAIYANG PLASTIC COMPANY
    Date Cleared
    2016-12-21

    (132 days)

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

    ZIBO DAIYANG PLASTIC COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile 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 Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.
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