NUC · Lubricant, Personal
Obstetrics/Gynecology · 21 CFR 884.5300 · Class 2
Overview
| Product Code | NUC |
|---|---|
| Device Name | Lubricant, Personal |
| Regulation | 21 CFR 884.5300 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.
Classification Rationale
(1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.
Special Controls
*Classification.* (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.
Recent Cleared Devices (20 of 240)
Showing 20 most recent of 240 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K254101 | Julva Velvé Water-Based Personal Lubricant | Golden Isles Medical, Inc. | Apr 16, 2026 | SESE |
| K260007 | Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg) | Hudi Pharma Srl | Apr 1, 2026 | SESE |
| K253983 | Water-based lubricant | Guangzhou Haoyimai Trading Co., Ltd. | Mar 6, 2026 | SESE |
| K251011 | Chiavaye Personal Moisturizer | Unipack, LLC | Dec 19, 2025 | SESE |
| K252935 | Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml) | Foshan Pingchuang Medical Technology Co., Ltd. | Dec 15, 2025 | SESE |
| K250488 | Cerynë Intimate Care | Ansella Therapeutics | Dec 12, 2025 | SESE |
| K251773 | Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.) | Shenzhen Yongquan Medical Devices Co., Ltd. | Sep 9, 2025 | SESE |
| K250142 | Water-based Lubricant | Global Protection Corp. | Aug 8, 2025 | SESE |
| K243972 | Plain Water-based Lubricant | Global Protection Corp. | Aug 8, 2025 | SESE |
| K242712 | LubriZenzs | Sk Zen, LLC | Jun 4, 2025 | SESE |
| K243107 | Water Solubility Human Body Lubricant | Dongguan Yanxuan Biotechnology Co., Ltd. | May 9, 2025 | SESE |
| K250629 | Sutil Rich Personal Lubricant | Hathor Professional Skincare , Ltd. | May 2, 2025 | SESE |
| K242958 | Joylux Intimacy Gel (PG3100) | Joylux, Inc. | Mar 20, 2025 | SESE |
| K241443 | Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118) | Hathor Professional Skincare , Ltd. | Jan 21, 2025 | SESE |
| K242645 | INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant | Project Chemistry, Inc. | Dec 6, 2024 | SESE |
| K240745 | ID Free Personal Lubricant | Westridge Laboratories, Inc. | Sep 27, 2024 | SESE |
| K242162 | Coconut Hybrid | Good Clean Love, Inc. | Sep 19, 2024 | SESE |
| K240081 | Human Lubricant | Jiangxi Wulinxiang Biological Technology Co., Ltd. | Aug 16, 2024 | SESE |
| K234099 | Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant | Select Labs, LLC | Jun 7, 2024 | SESE |
| K232040 | Gynatrof | Tyros Biopharma, Inc. | Mar 1, 2024 | SESE |
Top Applicants
- Biofilm, Inc. — 13 clearances
- United Consortium — 13 clearances
- CC Wellness, LLC — 10 clearances
- Church & Dwight Co., Inc. — 8 clearances
- Rb Health (Us), LLC — 8 clearances
