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510(k) Data Aggregation

    K Number
    K131832
    Device Name
    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
    Date Cleared
    2014-01-07

    (201 days)

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

    SHANDONG BINXIANG 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 of 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 Vinvl 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 D-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 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove. 80LYZ, and meets all requirement of ASTM Standard D5250-06.
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