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510(k) Data Aggregation

    K Number
    K071022
    Device Name
    POWDER-FREE VINYL EXAMINATION GLOVES
    Manufacturer
    GLORMED COLOMBIA S.A.
    Date Cleared
    2007-07-05

    (85 days)

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

    GLORMED COLOMBIA S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner against potentially infectious materials.
    Device Description
    Powder-Free Vinyl Examination Glove
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