Search Results

Winner® Self Seal Sterilization Pouch 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 ethylene oxide (EtO). It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

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 Winner® Self Seal Sterilization Pouch has the identical intended use and indication for use as the predicate devices, as well as, similar labeling.