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510(k) Data Aggregation

    K Number
    K023753
    Device Name
    VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E
    Manufacturer
    ARISTA LATINDO INDUSTRIAL LTD. P.T
    Date Cleared
    2003-03-25

    (137 days)

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

    ARISTA LATINDO INDUSTRIAL LTD. P.T

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Vinyl Examination Gloves, Pre-Powdered, with Vitamin E
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