Search Results

Surgical apparel are devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.

The standard, fabric- and poly-reinforced gowns are comprised of a single layer of SMS Polyolefin fabric. The fabric-reinforced gowns have an additional layer of SMS Polyolefin fabric in the sleeve and body areas; the poly-reinforced gowns have an additional layer of polyolefin film in the sleeve and body areas.

I am sorry, but I cannot provide an answer based on the provided text. The document describes a 510(k) summary for surgical gowns, outlining their intended use, materials, and substantial equivalence to existing devices. However, it does not contain any information about acceptance criteria, device performance, a study proving device meets acceptance criteria, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.

The document explicitly states: "Summary of testing:" at the end of the second page, but no testing details or results follow in the provided excerpts.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details.

Ask a specific question about this device