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510(k) Data Aggregation

    K Number
    K121992
    Device Name
    POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR
    Manufacturer
    XINWEI (SHANDONG) PLASTIC AND RUBBER PRODUCTS CO.,
    Date Cleared
    2012-10-16

    (102 days)

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

    XINWEI (SHANDONG) PLASTIC AND RUBBER PRODUCTS CO.,

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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 (21CFR 880.6250)
    Device Description
    Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Nitrile Patient Examination Glove, 80LZA; and meets all requirement of ASTM Standard D6319-10.
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