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Surgical gowns are intended to be worn by operating room personnel procedure to protect both the surgical patient and the operating room persomel from transfer of microorganisms, body fluids, and particulate material. This device is provided sterile.

Per ASNI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the standard (non-reinforced) surgical gowns meet Level 2 classification and the reinforced surgical gowns meet Level 3 classification.

Surgical gowns are intended to be worn by healthcare professionals to protect both the patient and the healthcare professional from the transfer or microorganisms, body fluids, and particulate material. The proposed devices are single use, disposable medical devices and ethylene oxide (EO) sterilized. They are available in six sizes: S, M, L, XL, XXL and XXXL.

The proposed surgical gowns are constructed of a Spunbond (SMS) nonwoven material, with cuffs made of polyester and elastic, offered in standard (non-reinforced) and reinforced surgical gowns, in blue color.

This is a 510(k) summary for a surgical gown, which is a low-risk medical device. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of AI algorithm performance. Therefore, many of the requested criteria, which are typically relevant for AI/ML device evaluations, are not applicable here.

Here's an analysis based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document provides a summary of performance testing in Table 2, outlining the test method, purpose, acceptance criteria, and result (Pass/Fail or specific finding).

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