(77 days)
A surgeon's-glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. (21CFR 878.4460)
Sterile Powder Free Latex Surgeon Gloves with Protein Content Labeling Claim (50 micrograms or less)
This document is a 510(k) clearance letter from the FDA for "Sterile Powder Free Latex Surgeon's Gloves with Protein Labeling Claim (50 Micrograms or Less Per Gram of Glove)". It does not contain information about acceptance criteria and device performance in the context of a study for an AI/ML powered device.
The information provided describes the regulatory classification of the gloves, the predicate device, and general regulatory requirements for marketing the device. It also includes the indicated use of the gloves.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, and AI/ML specific performance metrics from this document.
§ 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).