NUC
- 产品代码
- NUC
- 器械名称
- Lubricant, Personal
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 884.5300
- FDA 专业组
- Obstetrics/Gynecology
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 31 件
- 其中 Summary 已存档
- 25 份,可直接下载
- FDA 历史累计 510(k)
- 247 件(全部年份;本站只收录近三年的明细)
FDA 分类定义
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.
该代码近三年的 510(k)(31 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K261905 | 2026-08-07 | Bumlicious, LLC (DBA Bumlicious) | BUM Oil | |
| K261177 | 2026-07-09 | PINKSLIP, LLC | PINKSLIP Water-Based Personal Lubricant and Moisturi | |
| K261909 | 2026-07-06 | PCCA, Inc. | Plum Vagiceuticals Vaginal Moisturizing Suppositori | |
| K254011 | 2026-06-22 | LBDO Group, Inc. | Flow Water-Based Personal Lubricant | |
| K261292 | 2026-06-11 | PR Personal Care Laboratories | PR Water-Base Lube Personal Lubricant (PR Water-Base | |
| K252914 | 2026-06-09 | Hathor Professional Skincare , Ltd. | Sutil Pure Personal Lubricant (models 1148, 1145, 11 | |
| K260068 | 2026-05-21 | Pjur Group Luxembourg S.A. | pjur NATURE Touch, 100 ml | FDA |
| K254101 | 2026-04-16 | Golden Isles Medical, Inc. | Julva Velvé Water-Based Personal Lubricant | |
| K260007 | 2026-04-01 | Hudi Pharma Srl | Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyalu | |
| K253983 | 2026-03-06 | Guangzhou Haoyimai Trading Co., Ltd. | Water-based lubricant | |
| K251011 | 2025-12-19 | Unipack, LLC | Chiavaye Personal Moisturizer | |
| K252935 | 2025-12-15 | Foshan Pingchuang Medical Technology C | Hybrid personal lubricant (water&silicone) (5ml, 8ml | — |
| K250488 | 2025-12-12 | Ansella Therapeutics | Cerynë Intimate Care | FDA |
| K251773 | 2025-09-09 | Shenzhen Yongquan Medical Devices Co., | Water-soluble Personal Lubricant (Satin Gel Vitamin | |
| K250142 | 2025-08-08 | Global Protection Corp. | Water-based Lubricant | — |
| K243972 | 2025-08-08 | Global Protection Corp. | Plain Water-based Lubricant | — |
| K242712 | 2025-06-04 | Sk Zen, LLC | LubriZenzs | |
| K243107 | 2025-05-09 | Dongguan Yanxuan Biotechnology Co., Lt | Water Solubility Human Body Lubricant | |
| K250629 | 2025-05-02 | Hathor Professional Skincare , Ltd. | Sutil Rich Personal Lubricant | |
| K242958 | 2025-03-20 | Joylux, Inc. | Joylux Intimacy Gel (PG3100) | |
| K241443 | 2025-01-21 | Hathor Professional Skincare , Ltd. | Sutil Luxe Personal Lubricant (models 1126, 0009, 00 | |
| K242645 | 2024-12-06 | Project Chemistry, Inc. | INA Moisturizing Intimate Lubricant Water-Based Pers | |
| K240745 | 2024-09-27 | Westridge Laboratories, Inc. | ID Free Personal Lubricant | |
| K242162 | 2024-09-19 | Good Clean Love, Inc. | Coconut Hybrid | |
| K240081 | 2024-08-16 | Jiangxi Wulinxiang Biological Technolo | Human Lubricant | |
| K234099 | 2024-06-07 | Select Labs, LLC | Select Hybrid Personal Lubricant, and Select Pure Si | FDA |
| K232040 | 2024-03-01 | Tyros Biopharma, Inc. | Gynatrof | |
| K231794 | 2023-12-22 | Viramal Limited | Elegant Advanced CompHort | |
| K232093 | 2023-12-01 | Woo Essentials, Inc. | Woo More Play Coconut Love Oil | |
| K232091 | 2023-10-22 | CC Wellness, LLC | JO Coconut Hybrid Cooling Personal Lubricant | |
| K232090 | 2023-10-11 | CC Wellness, LLC | JO Coconut Hybrid Warming Personal Lubricant |
FDA 官方分类页: NUC
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA(CC0 公有领域),不构成注册策略建议。