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510(k) Data Aggregation

    K Number
    K231973
    Device Name
    PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove
    Manufacturer
    Ineo Tech Sdn Bhd
    Date Cleared
    2023-09-29

    (88 days)

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

    Ineo Tech Sdn Bhd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The polyisoprene powder free, black colour surgical gloves are radiation attenuating and intended to be worn by operating room personal to protect a surgical wound from contamination
    Device Description
    The Polyisoprene Powder Free Black Color Radiation Attenuating Surgical Glove is a disposable sterile powder-free medical device made of polyisoprene that is intended to be worn by operating room personnel to protect a surgical wound from contamination. The glove contains radiation-attenuating particles to reduce the exposure from harmful ionizing scattered or secondary radiation on the operator's hand during fluoroscopic procedures. The glove is proposed in two (2) options. The Model 2 are made with exactly the same material and composition and differ only by their thicknesses and therefore their attenuation properties.
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