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510(k) Data Aggregation

    K Number
    K130807
    Device Name
    POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
    Manufacturer
    HOPE PLASTIC CO., LTD.
    Date Cleared
    2014-02-07

    (319 days)

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

    HOPE PLASTIC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Powder Free Vinyl Patient Examination Gloved) is a non-sterile disposable device intended for medical purposs that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
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