K240081 is an FDA 510(k) clearance for the Human Lubricant. This device is classified as a Lubricant, Personal (Class II - Special Controls, product code NUC).
Submitted by Jiangxi Wulinxiang Biological Technology Co., Ltd. (Nanchang, CN). The FDA issued a Cleared decision on August 16, 2024, 218 days after receiving the submission on January 11, 2024.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300. This Device Is A Personal Lubricant, For Penile And/or Vaginal Application, Intended To Moisturize And Lubricate, To Enhance The Ease And Comfort Of Intimate Sexual Activity, And Supplement The Body's Natural Lubrication. This Product May Or May Not Be Compatible With Natural Rubber Latex, Polyisoprene, And/or Polyurethane Condoms..
| 510(k) Number | K240081 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 11, 2024 |
| Decision Date | August 16, 2024 |
| Days to Decision | 218 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | NUC - Lubricant, Personal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5300 |
| Definition | This Device Is A Personal Lubricant, For Penile And/or Vaginal Application, Intended To Moisturize And Lubricate, To Enhance The Ease And Comfort Of Intimate Sexual Activity, And Supplement The Body's Natural Lubrication. This Product May Or May Not Be Compatible With Natural Rubber Latex, Polyisoprene, And/or Polyurethane Condoms. |