(273 days)
A SURGEON'S GLOVE IS A DEVICE MADE OF NATURAL OR SYNTHETIC RUBBER INTENDED TO BE WORN BY OPERATING ROOM PERSONNEL TO PROTECT A SURGICAL WOUND FROM CONTAMINATION.
SURGEON'S GLOVE, STERILE - TYPE II
The provided documents are a 510(k) premarket notification approval letter and an "Indications for Use" statement for "Sterile Powder-Free Nitrile Surgeons Gloves". These documents do not contain information about acceptance criteria or a study proving that a device meets such criteria.
The 510(k) letter states that the device is "substantially equivalent" to predicate devices, meaning it has the same intended use and technological characteristics as a legally marketed device, or has different technological characteristics but does not raise new questions of safety and effectiveness and is as safe and effective as a legally marketed device.
Therefore, I cannot provide the requested information based on the provided text.
§ 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).