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 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES > SUBPART G—General Hospital and Personal Use Miscellaneous Devices (§880.6025 to §880.6992) > 880.6375—Patient lubricant.

880.6375—Patient lubricant.

(a) Identification. A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
(b) Classification. Class I (general controls).

Code of Federal Regulations

[45 FR 69682-69737, Oct. 21, 1980, as amended at 66 FR 46952, Sept. 10, 2001]