{"data":{"id":"us/21-cfr-880.6375","jurisdiction":"us","citation":"21 CFR 880.6375","heading":"Patient lubricant.","body":"(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.\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES","Subpart G—General Hospital and Personal Use Miscellaneous Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"1d07d0d5273662be975c75e51e5790a085ce3fc7ad6824fc3fb1a479d2156c37","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-880.6350","next":"us/21-cfr-880.6430"},"notice":"GroundRules: Original legal text. Not legal advice."}