Search Results
Found 2 results
510(k) Data Aggregation
(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.
Ask a specific question about this device
(170 days)
Ask a specific question about this device
Page 1 of 1