21 CFR 878.4460 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 1272-1299) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 1272-1299) — Medical Devices (Subpart A To § 898.14) — General And Plastic Surgery Devices (§ 878.1 To § 878.5910) — Surgical Devices (§ 878.4010 To § 878.5040) — Surgeon's glove.

4 Aug 2016

(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).

21 CFR 878.4460
[53 FR 23872, June 24, 1988, as amended at 66 FR 46952, Sept. 10, 2001]