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510(k) Data Aggregation

    K Number
    K092100
    Device Name
    POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    TANGSHAN HONGXING PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2009-09-18

    (66 days)

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

    TANGSHAN HONGXING 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
    Patient Vinyl Examination Gloves, PowderFree, Non-Sterile
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