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Winner® Self Seal Sterilization Pouch with Steam and Ethylene Oxide Process Indicators is intended to be used to enclose another medical device that is to be sterilized by a health provider by steam 121°C for 15 minutes or greater than or equal to 600 mg/l of ethylene oxide (EtO) for 1 hour at 55° C and 70%RH. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The process indicators on the pouches are intended to demonstrate that the device has been exposed to the steam or EtO sterilization process and to distinguish between processed and unprocessed devices.

These pouches are manufactured from a medical grade paper and plastic film that are heat sealed on three sides. The fourth side has an adhesive strip that is used to seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam or ethylene oxide gas. The Sterilization Pouch with indicators has the identical intended use, components, and manufacturing methods as our previous Self Seal Sterilization Pouch.

Winner Medical facemask / shield are intended to be used by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids and particulate matter.

These masks are pleated 3-ply masks with an inner and outer layer that sandwich a polypropylene filter material. On some masks a plastic shield with a non-fog coating is incorporated. The masks are identical to the predicate devices in design, materials used and performance in non-clinical testing. This testing included bacterial filtration efficiency (BFE), pressure differential (Delta P), flammability, ISO skin irritation and sensitization.