(37 days)
A glove to be worn by operating room personnel to protect a surgical wound from contamination.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "Omni Pro Latex Surgical Glove, Powdered." This type of document does not contain the information requested in the prompt, as it is a regulatory clearance and not a study report or technical specification.
Therefore, I cannot provide the detailed information about acceptance criteria, study design, expert qualifications, or ground truth establishment based on the provided text. This letter confirms that the device is substantially equivalent to a predicate device and can be marketed, but does not include the performance study details you are asking for.
§ 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).