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The Dukal SMS sterilization wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using: · In a steam sterilization pre-vacuum cycle at 270°F / 132°C for 4 minutes o Models 100, 200 and 300 were validated for dry times of 20 minutes: models 400, 500 and 600 were validated for dry times of 30 minutes. · In 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F / 55°C and 40-80% relative humidity for 60 minutes. o The wrap was validated for aeration times for EO sterilization of 16 hours at 40.0 ℃. Dukal SMS sterilization wraps are intended to allow sterilization of the enclosed medical device(s), and also to maintain sterility of the enclosed device(s) for 6 months or until opened. The devices are intended for over-the-counter use and are single use disposable sterilization wraps. Test results validated that the Dukal SMS sterilization wraps allowed sterilization of the enclosed medical device(s) by ethylene oxide sterilization and by pre-vacuum cycles. These models of the Dukal SMS sterilization wrap have been validated for use with the ethylene oxide and pre-vacuum cycles listed in below table:

Models 100, 200, 300, 400, 500 and 600 Available in one or two sheets of blue nonwoven Polypropylene fabric. Each sheet of fabric is composed of three thermally- bonded layers consisting of a Meltblown polypropylene layer surrounded by Spunbond polypropylene layers (SMS).