NUC — Lubricant, Personal Class II
FDA product code NUC covers "Lubricant, Personal", a Class II medical device regulated under 21 CFR 884.5300. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NUC
- Device Class
- Class II
- Regulation Number
- 884.5300
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261177 | pinkslip | PINKSLIP Water-Based Personal Lubricant and Moisturizer | July 9, 2026 |
| K261909 | pcca | Plum Vagiceuticals Vaginal Moisturizing Suppositories | July 6, 2026 |
| K254011 | lbdo group | Flow Water-Based Personal Lubricant | June 22, 2026 |
| K261292 | pr personal care laboratories | PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) | June 11, 2026 |
| K252914 | hathor professional skincare | Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) | June 9, 2026 |
| K260068 | pjur group luxembourg | pjur NATURE Touch, 100 ml | May 21, 2026 |
| K254101 | golden isles medical | Julva Velvé Water-Based Personal Lubricant | April 16, 2026 |
| K260007 | hudi pharma | Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Supposito | April 1, 2026 |
| K253983 | guangzhou haoyimai trading co | Water-based lubricant | March 6, 2026 |
| K251011 | unipack | Chiavaye Personal Moisturizer | December 19, 2025 |
| K252935 | foshan pingchuang medical technology co | Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30 | December 15, 2025 |
| K250488 | ansella therapeutics | Cerynë Intimate Care | December 12, 2025 |
| K251773 | shenzhen yongquan medical devices co | Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin G | September 9, 2025 |
| K250142 | global protection | Water-based Lubricant | August 8, 2025 |
| K243972 | global protection | Plain Water-based Lubricant | August 8, 2025 |
| K242712 | sk zen | LubriZenzs | June 4, 2025 |
| K243107 | dongguan yanxuan biotechnology co | Water Solubility Human Body Lubricant | May 9, 2025 |
| K250629 | hathor professional skincare | Sutil Rich Personal Lubricant | May 2, 2025 |
| K242958 | joylux | Joylux Intimacy Gel (PG3100) | March 20, 2025 |
| K241443 | hathor professional skincare | Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanill | January 21, 2025 |