(54 days)
A powder-free sterile surgeon's glove is a disposable device made of de-proteinised latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Eclipse, Non-pyrogenic, latex, powder free, sterile surgeon's glove
The provided document is a 510(k) premarket notification letter for a surgeon's glove, which is a medical device. This type of document does not contain information about acceptance criteria and study data for an AI/ML-powered medical device. It pertains to traditional medical device clearance based on substantial equivalence to a predicate device.
Therefore, I cannot extract the requested information from the provided text. The questions posed are related to the evaluation of AI/ML device performance, which requires a different kind of documentation (e.g., a clinical study report, detailed performance testing results).
§ 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).