(194 days)
This surgeon's glove is a device made of polyisoprene rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
This surgeon's glove is a device made of polyisoprene rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The provided text is a 510(k) clearance letter from the FDA for a surgical glove. It does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. The document is a regulatory approval for a medical device, specifically a surgical glove, based on its substantial equivalence to a legally marketed predicate device.
Therefore, I cannot provide the requested information based on the given 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).