(142 days)
The powdered free sterile natural rubber latex surgical gloves is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The device is a sterile, single-use, non-pyrogenic, latex surgical glove. The proposed device is made of natural rubber latex. Per standard ASTM D3577-09(15), the rubber surgical gloves classification is: "Type 1-gloves compounded primarily from natural rubber latex." The proposed device is provided EO sterilized to achieve the sterility Assurance Level (SAL) of 10-6. The gloves are powdered free and available in four sizes 7, 7.5, 8, 8.5 to be suitable for user's hand. The Glove palm has textured surface.
The provided text is a 510(k) Summary for a medical device: "Powdered Free Sterile Natural Rubber Latex Surgical Gloves." This document describes the device, its intended use, and comparative non-clinical performance testing against a predicate device to demonstrate substantial equivalence.
It does not describe:
- An AI/ML-driven device.
- A study proving an AI/ML meets acceptance criteria.
- Any ground truth establishment or expert adjudication.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Training set details.
Therefore,Based on the provided FDA 510(k) Summary for "Powdered Free Sterile Natural Rubber Latex Surgical Gloves," the document does not describe an AI/ML-driven device or any study related to AI/ML performance.
The 510(k) submission focuses on demonstrating substantial equivalence of the surgical gloves to a predicate device through non-clinical performance testing. The information requested in the prompt, such as acceptance criteria for AI/ML performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment, are not applicable to the content of this document, as it pertains to a physical medical device (surgical gloves) and not a software algorithm or AI.
Therefore, I cannot extract the requested information from the provided text.
§ 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).