(292 days)
A surgeon's glove is a device made of natural or systemic rubber insended to be worn by operating room personnel to protect a surgical wound from contamination.
Elastyren Powder-Free Surgical Glove
This document is a 510(k) premarket notification decision letter from the FDA for the Elastyren Powder-Free Surgical Glove. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory approval letter, not a device performance study report.
§ 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).