Search Results

This surgical glove is a device made of a neoprene – polyisoprene synthetic material intended to be worn by operating room personnel to protect a surgical wound from contamination.

Nuzone X2A , Neoprene - Polyisoprene Blend Powder Free sterile surgical Glove Polymer andAloe vera coated natural or green colour.

The provided document is a 510(k) clearance letter from the FDA for a surgical glove. It does not contain any information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.

Therefore, I cannot answer your request based on the provided text. The information requested typically applies to AI/ML device submissions, which include performance metrics like sensitivity, specificity, or image quality assessments, often compared against a ground truth established by experts.

This document is a regulatory approval for a physical medical product (surgical gloves) based on substantial equivalence to a predicate device, and the evaluation criteria are related to manufacturing, safety, and physical properties, not AI/ML performance.

Ask a specific question about this device