(88 days)
A powder-free sterile surgeon's glove is a disposable device made of Poly-Isoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Poly-Isoprene non-latex sterile powder-free surgeon's glove with Non-pyrogenic statement
The provided document is a 510(k) clearance letter from the FDA for a Biogel Skinsense Poly-Isoprene Powder-free Surgeon's Glove With Non-pyrogenic statement. This type of medical device (a surgeon's glove) is classified as a Class I device and does not typically involve complex performance studies with acceptance criteria, expert adjudication, or AI components as would be found for, for example, diagnostic imaging software.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment is not applicable to this device and the provided document.
The FDA's review for this device primarily focuses on demonstrating substantial equivalence to a predicate device already on the market, meaning it has the same intended use and technological characteristics as a legally marketed device, or different technological characteristics that do not raise new questions of safety and effectiveness. The document itself is the clearance letter, not a detailed study report.
The "Indications for Use" section (document {2}) states the purpose of the device: "A powder-free sterile surgeon's glove is a disposable device made of Poly-Isoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants." The "acceptance criteria" in this context would typically relate to manufacturing standards, sterility, physical properties (e.g., tensile strength, barrier integrity), and biocompatibility, rather than performance metrics of a diagnostic or therapeutic algorithm. These would be met through standard quality control and testing procedures for medical gloves, but not detailed in this 510(k) clearance letter.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).