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The REXAM Fracture Resistant Pouch is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The chemical process indicator on the REXAM Fracture Resistant Pouch is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.

The predicate device and the REXAM Fracture Resistant Pouch are constructed of sterilizable kraft paper sealed to the polypropylene surface of a polyester-polypropylene plastic film lamination. Three sides of the pouch are sealed during manufacture. There are two versions of the REXAM Fracture Resistant Pouch: (1) a final heat seal closure of the paper and plastic film laminate components, and (2) a final self-seal closure employing a pressure sensitive self-seal tape assembled on the paper component and sealed to the polyester layer of the plastic film laminate. Both types of final closures are applied by the health care provider. A chemical sterilization process indicator for steam or ethylene oxide sterilization, or both, may be incorporated to monitor exposure to the sterilant.

The Rexam Self-Seal Tyvek® Pouch is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider using a sterilization process where a non-cellulose pouch is indicated. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The chemical process indicator on the Rexam Self-Seal Tyvek® Pouch is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.

The Rexam Self-Seal Tyvek® Pouch is constructed of medical grade Tyvek® sealed to polyethylene/polyester film. A chemical sterilization process indicator may be incorporated to monitor one or more of the sterilization process parameters. The final seal of the pouch is applied by the health care provider using the pressure sensitive self-seal tape closure. The self-seal tape closure facilitates manual sealing as an alternate method to heat sealing.