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The Granton® Medical 121-135°C Self-Seal Sterilization Pouches are intended to be used to enclose another medical device that is to be steam sterilized at 121-135°C by a healthcare provider, following the ANSI/AAMI ST-46 sterilization recommendations. The Self Seal Sterilization Pouches maintain the enclosed device's sterility until used.

The proposed Granton® Medical 121-135°C Self-Seal Sterilization Pouches (121-135°C Sterilization Pouches) are essentially identical in design and materials to Granton Medical's Self Seal Sterilization Pouch (Self Seal Sterilization Pouch) described in K023025. Like the predicate Self Seal Sterilization Pouch, the 121-135°C Sterilization Pouches are single use bags with an adhesive strip on the open end for sealing the bag prior to sterilization. The six pouch sizes available for the proposed 121-135°C Sterilization Pouches are identical to those of the predicate Self Seal Sterilization Pouch. The proposed 121-135°C Sterilization Pouches are manufactured with a throughput process indicator applied to the paper surface of the pouch using a flexographic printing method.

The Granton Medical Sterilization Pouches are to be used to enclose another medical device that is to be 121°C gravity steam or ethylene oxide sterilized by a health care provider, following the ANSI/AAMI ST-46 OR ST-41 sterilization recommendations.

Self Seal Sterilization Pouch