(206 days)
This sterile nitrile powder free surgeon's glove is intended to be worn by operating room personnel to protect a surgical wound from contamination.
Nitrilon™ Correct Touch® Sterile Nitrile Powder Free Surgeon's Glove
This is an FDA 510(k) clearance letter for sterile nitrile powder-free surgical gloves. It does not contain the detailed information required to answer your questions about acceptance criteria, study design, expert qualifications, or ground truth for a medical device. This type of document confirms that a device is "substantially equivalent" to a previously marketed device, without necessarily detailing specific performance studies in the way you've outlined.
Therefore, I cannot provide the requested information from 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).