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    K Number
    K230832
    Device Name
    Powdered Free Sterile Natural Rubber Latex Surgical Gloves
    Manufacturer
    The Egyptian Company For Medical & Electronic Industries
    Date Cleared
    2023-08-16

    (142 days)

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

    **The Egyptian Company For Medical **& Electronic Industries

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The powdered free sterile natural rubber latex surgical gloves is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Device Description
    The device is a sterile, single-use, non-pyrogenic, latex surgical glove. The proposed device is made of natural rubber latex. Per standard ASTM D3577-09(15), the rubber surgical gloves classification is: "Type 1-gloves compounded primarily from natural rubber latex." The proposed device is provided EO sterilized to achieve the sterility Assurance Level (SAL) of 10-6. The gloves are powdered free and available in four sizes 7, 7.5, 8, 8.5 to be suitable for user's hand. The Glove palm has textured surface.
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