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The Medline Prevention CoolZone Gown is a sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Medline Prevention CoolZone Gown meets the Level 4 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.

The Medline Prevention CoolZone Gown is manufactured from a breathable, non-woven, polypropylene fabric, with an SMS material at the back. The fabric is a three-layer lamination resistant to liquid penetration. The film layer is a multi-layer polypropylene olefin, breathable film. The Medline Prevention CoolZone Gown has been tested according to AAMI PB70:2012 and meets Level 4 requirements of the AAMI Liquid Barrier classifications for a surgical gown. The sterilized version of the device is a folded gown packaged with one hand towel wrapped inside the CSR wrap and placed inside a peel pouch. The Medline Prevention CoolZone Gowns are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.

The provided document describes the predicate equivalence of a medical device, specifically the Medline Prevention CoolZone Gown, rather than an AI/ML powered device. Therefore, the acceptance criteria and study details requested in the prompt, which are typically relevant for AI/ML device validation, are not present in the document.

The document focuses on non-clinical testing and comparison to a predicate device to establish substantial equivalence for a surgical gown. It does not involve AI models, data sets, expert reviews, or MRMC studies.

Therefore, I cannot provide the requested information based on the given document.

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