21 C.F.R. § 880.6375 Patient lubricant.
Title 21 - Food and Drugs
(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). [45 FR 69682–69737, Oct. 21, 1980, as amended at 66 FR 46952, Sept. 10, 2001]
Title 21: Food and Drugs
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart G—General Hospital and Personal Use Miscellaneous Devices
§ 880.6375 Patient lubricant.
