(122 days)
A powder-free sterile surgeon's glove is a disposable device made of Natural Rubber Latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Biogel Latex Sterile Powder-Free Surgeon's Glove with Low Dermatitis Potential and Protein Content Labeling Claim (50 micrograms or less)
I apologize, but the provided text only contains a 510(k) clearance letter from the FDA for a surgeon's glove. It does not include information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked. This document is a regulatory approval notice, not a technical report detailing the device's validation.
Therefore, I cannot extract the requested information from the given input.
§ 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).