(87 days)
A BPG powdered latex surgical glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. This excludes the lubricating or dusting powder used in the glove.
Powdered, Latex Surgical Glove
This document is an FDA 510(k) clearance letter for a Powdered Latex Surgical Glove. It is a regulatory approval document and does not contain any information about a study or acceptance criteria related to a medical AI/ML device.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, ground truth, or MRMC comparative effectiveness studies because this document pertains to a physical medical device (surgical gloves), not an AI/ML system.
§ 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).