Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K110536
    Device Name
    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
    Date Cleared
    2012-03-19

    (388 days)

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

    ZIBO TENGYUE PLASTIC 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 (21CFR 880.6250)
    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 (21CFR 880.6250). Our Powder-Free Vinyl Patient Examination Gloves do not contain any UPS powder according to the results of testing conducted on the gloves. The residual powder testing is conducted per standards of ASTM IN-6124-06, which demonstrates that the powder free glove is less than 2mg/pc. Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LtZ, and meets all requirement of ASTM Standard D5250-06 (2011).
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1