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510(k) Data Aggregation

    K Number
    K050181
    Device Name
    MEDIGLOVES STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES
    Manufacturer
    Date Cleared
    2005-04-13

    (76 days)

    Product Code
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIGLOVES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A powder-free surgeon's glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
    Device Description
    The gloves are made of polyisoprene synthetic latex and green colored. They are washed with Ammonia solution to leach off mold release powder, chemical and protein before they are chlorinated and inner coated with the solution of coating material for ease of donning. The gloves are tested for pinhole by water leak test machine. They are sterilized by gamma irradiation.
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