(109 days)
This surgeon's glove is a device made of Flexylon intended to be worn by operating room personnel to protect a surgical wound from contamination.
Finessis Zero Flexylon Powder Free Sterile White Surgical Glove
This document is an FDA 510(k) clearance letter for a surgical glove. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the format requested. The document primarily focuses on the regulatory clearance of a medical device (surgical glove) and confirms its substantial equivalence to a predicate device.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication method, MRMC study, standalone performance), or ground truth establishment.
§ 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).