(52 days)
This surgeon's glove is made of natural rubber latex and is intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.
Medline Powder-Free Latex Surgical Gloves, Sterile, w/ or w/o Aloe Vera and with Protein Content Labeling Claim (50 micrograms or less) - Green/Brown/Natural colors
The provided text is a 510(k) clearance letter from the FDA for surgical gloves. It does not contain information about acceptance criteria or specific studies proving device performance beyond a general statement of "substantial equivalence" to predicate devices.
Therefore, I cannot fulfill the request to describe acceptance criteria and associated study details based on the provided input. This document is a regulatory approval notice, not a detailed technical report or clinical study summary.
Specifically:
- There is no table of acceptance criteria or reported device performance.
- There is no information on sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth for either test or training sets.
§ 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).