(14 days)
The surgical glove is a device made of synthetic latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.
The Powder Free Polymer Coated Green Neoprene Surgical Gloves, Sterile are made of synthetic rubber latex intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.
The provided text is a 510(k) summary for a medical device, specifically Powder Free Polymer Coated Green Neoprene Surgical Gloves, Sterile. This type of document is for regulatory clearance of medical devices, demonstrating substantial equivalence to a predicate device, rather than a clinical study report proving diagnostic performance of an AI algorithm.
Therefore, many of the requested categories for AI algorithm studies (such as sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this document.
However, I can extract the acceptance criteria and the "study" (which in this context refers to the testing performed to demonstrate compliance with standards) that proves the device meets them.
Here's the information derived from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| CHARACTERISTICS | STANDARDS / Acceptance Criteria | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | ASTM D 3577 - 01aE2 | Meets |
| Physical Properties | ASTM D 3577 - 01aE2 | Meets |
| Freedom from pinholes | ASTM D 3577 - 01aE2; FDA 21 CFR 800.20 (Pinhole AQL) | Meets |
| Powder Residual | ASTM D 6124 - 01 | Meets ( |
§ 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).