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This device is 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 maintain sterility of the enclosed device until used. It is intended for use with either steam or ethylene oxide sterilization methods.

Secure-Wrap® Sterilization Wrap

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA letter granting substantial equivalence for the "Secure-Wrap® Sterilization Wrap" and outlines regulatory information. It does not include details about device performance metrics, study design, sample sizes, or expert qualifications.

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