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510(k) Data Aggregation

    K Number
    K111857
    Device Name
    SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE
    Manufacturer
    INMED GLOVES FACTORY
    Date Cleared
    2011-09-21

    (83 days)

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

    INMED GLOVES FACTORY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A Synthetic Vinyl Examination Glove, is a non-sterile 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
    Powder Free, Synthetic Vinyl Examination Gloves
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