(7 days)
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.
§ 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).