§ 880.6375. Patient lubricant.
93 words·~1 min read·
/us/cfr/t21/s§ 880.6375·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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). Except when the device is a vaginal patient lubricant or an oral lubricant, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 46952, Sept. 10, 2001; 84 FR 71815, Dec. 30, 2019]
Connections1 cite this
Cited by 1 section
Citation graph
cites case law
§ 880.6375
Patient lubricant.
Fed. Reg.×1
Cites 0Cited by 1 across 1 source