(175 days)
A powder-free nitrile surgeon's glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hands, usually in surgical setting to provide a barrier against potentially infectious materials and other contaminants.
A powder-free nitrile surgeon's glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hands, usually in surgical setting to provide a barrier against potentially infectious materials and other contaminants.
The provided document is a 510(k) clearance letter from the FDA for medical gloves. This type of document declares that a device is substantially equivalent to a predicate device already on the market. It does not contain information about formal acceptance criteria, device performance studies, sample sizes, expert ground truthing, or multi-reader multi-case studies, which are typically found in detailed technical reports or clinical study summaries.
Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study 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).