§ 878.4460 - Non-powdered surgeon's glove.

§ 878.4460 SurgeonNon-powdered surgeon's glove.

Cross Reference

Link to an amendment published at 81 FR 91730, Dec. 19, 2016.

(a) Identification. A non-powdered surgeon's glove is a device made of natural or synthetic rubber intended to be worn by on the hands of operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excludedA 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).

[53 FR 23872, June 24, 1988, as amended at 66 FR 46952, Sept. 10, 2001; 81 FR 91730, Dec. 19, 2016]