(65 days)
A Sterile Powder Free Latex Surgical Glove is a disposable device made of natural rubber latex and is intended to be worn by operating room personnel to protect a surgical wound from contamination.
Sterile Powder Free Latex Surgical Gloves
The provided document is a 510(k) substantial equivalence determination letter from the FDA for Maxter Sterile Powder Free Latex Surgical Gloves. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this letter does not contain any information regarding specific acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies. These details would typically be found in the 510(k) submission itself or a separate study report, which is not provided here.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. The document is essentially the FDA's approval notice, not the technical submission with performance data.
§ 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).