21 CFR 880.6375 — Lubricant, Patient
General Hospital (HO) · Part 880 Subpart G—General Hospital and Personal Use Miscellaneous Devices · § 880.6375
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KMJ | Lubricant, Patient | 1 | 49 | |
| MMS | Lubricant, Vaginal, Patient | 1 | 0 | 3rd Party |
| ONK | Oral Lubricant | 1 | 1 | 3rd Party |
