NUC — Lubricant, Personal Class II
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 |
|---|---|---|---|
| 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 |
| K242645 | project chemistry | INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant | December 6, 2024 |
| K240745 | westridge laboratories | ID Free Personal Lubricant | September 27, 2024 |
| K242162 | good clean love | Coconut Hybrid | September 19, 2024 |
| K240081 | jiangxi wulinxiang biological technology co | Human Lubricant | August 16, 2024 |
| K234099 | select labs | Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant | June 7, 2024 |
| K232040 | tyros biopharma | Gynatrof | March 1, 2024 |
| K231794 | viramal limited | Elegant Advanced CompHort | December 22, 2023 |
| K232093 | woo essentials | Woo More Play Coconut Love Oil | December 1, 2023 |