(262 days)
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.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.