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510(k) Data Aggregation

    K Number
    K111297
    Device Name
    SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)
    Manufacturer
    PREMIER MEDICAL GLOVES FACTORY
    Date Cleared
    2011-06-16

    (38 days)

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

    PREMIER MEDICAL GLOVES FACTORY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Synthetic Vinyl Examination Glove, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Synthetic Vinyl Examination Gloves, Powder-Free
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