CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 878—GENERAL AND PLASTIC SURGERY DEVICES > SUBPART E—Surgical Devices (§878.4010 to §878.5040) > 878.4460—Surgeon's glove.

878.4460—Surgeon's glove.

(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).

Code of Federal Regulations

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