(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]