(36 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
Pre-Powdered Sterile Latex Surgeon's Gloves (Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram)
The provided text is related to the FDA 510(k) premarket notification for "Pre-Powdered Sterile Latex Surgeon's Gloves." It's a regulatory document confirming substantial equivalence to a predicate device, not a study report detailing acceptance criteria and performance of a new device in the context of AI/software or medical imaging.
Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance for a device proving it meets acceptance criteria cannot be extracted from this document.
This document specifically grants clearance based on the substantial equivalence of the described gloves to existing legally marketed devices, under the regulation 878.4460 for Surgeon's Gloves, product code KGO. It does not contain an independent technical study or performance evaluation with the kind of metrics you've asked for.
§ 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).