(a) Identification. A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded.
(b) Classification. Class I (general controls). [53 FR 23872, June 24, 1988, as amended at 66 FR 46952, Sept. 10, 2001]