(585 days)
This Surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
MODEL 1) SURGTEX Prepowdered surgical gloves. MODEL 2) SURGTEX PF Powderfree surgical gloves. With protein content labeling claim 50 ug/dm2 or less per glove of extractable protein.
The provided document is a 510(k) premarket notification letter from the FDA regarding surgical gloves (SURGTEX prepowdered and SURGTEX PF powderfree) with a protein content labeling claim. This document does not contain information about acceptance criteria or a study that proves a device meets those criteria, as it is a regulatory approval letter for a medical device (surgical gloves). It confirms that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information based on the content of this document. The questions you've asked are typically related to the performance evaluation of more complex diagnostic or therapeutic devices, often involving AI or software components, and would require detailed study reports that are not present here.
To answer your request, I would need a document that describes:
- Acceptance criteria for a specific device's performance (e.g., sensitivity, specificity, accuracy thresholds for an AI-powered diagnostic).
- The design and results of a study conducted to demonstrate that the device meets those criteria.
§ 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).