OFNat Lubricant (L15)
FDA 510(k) K221243 · Suretex Limited
510(k) numberK221243
Submission
- Device name
- OFNat Lubricant (L15)
- Applicant
- Suretex Limited
Tambon Khao Kwai, Amphur Phunphin, TH - Received
- May 2, 2022
- Decision date
- September 30, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NUC – Lubricant, Personal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5300
- Specialty
- Obstetrics/Gynecology
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.
Other 510(k)s with product code NUC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253989 | HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based…NUC · Traditional | Maxigen Biotech, Inc. | 09/03/2026SE |
| K261905 | BUM OilNUC · Traditional | Bumlicious, LLC (DBA Bumlicious) | 08/07/2026SE |
| K261177 | PINKSLIP Water-Based Personal Lubricant and MoisturizerNUC · Traditional | Pinkslip, LLC | 07/09/2026SE |
| K261909 | Plum Vagiceuticals Vaginal Moisturizing SuppositoriesNUC · Traditional | PCCA, Inc. | 07/06/2026SE |
| K254011 | Flow Water-Based Personal LubricantNUC · Traditional | LBDO Group, Inc. | 06/22/2026SE |
| K261292 | PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)NUC · Traditional | PR Personal Care Laboratories | 06/11/2026SE |
| K252914 | Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)NUC · Traditional | Hathor Professional Skincare , Ltd. | 06/09/2026SE |
| K260068 | pjur NATURE Touch, 100 mlNUC · Traditional | Pjur Group Luxembourg S.A. | 05/21/2026SE |
| K254101 | Julva Velvé Water-Based Personal LubricantNUC · Traditional | Golden Isles Medical, Inc. | 04/16/2026SE |
| K260007 | Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA…NUC · Traditional | Hudi Pharma Srl | 04/01/2026SE |
More from Hudi Pharma Srl
| 510(k) | Device | Decision |
|---|---|---|
| K252521 | LifeStyles® HydraFeel Natural Rubber Latex CondomHIS · Abbreviated | 11/18/2025SE |
| K232470 | Polyisoprene Extra Large CondomMOL · Abbreviated | 05/09/2024SE |
| K231908 | 45 Micron Polyisoprene CondomMOL · Traditional | 10/27/2023SE |
| K232279 | LifeStyles NRL Textured CondomHIS · Abbreviated | 10/05/2023SE |
| K213921 | Microthin Natural Rubber Latex CondomHIS · Abbreviated | 04/28/2022SE |
| K030176 | Lifestyles, Contempo or Private Label-Male Latex Condom with Desensitizing LubricantHIS · Abbreviated | 04/17/2003SE |
| K010371 | Lifestyles, Contempo or Private Label, Male Latex Condom with Glycerine LubricantHIS · Abbreviated | 04/27/2001SE |
| K941258 | Latex CondomHIS · Traditional | 12/06/1995SE |
| K942858 | Latex Condoms W/Spermicidal Lubricant (NONOXYNOL-9)HIS · Traditional | 05/18/1995SE |
| K910284 | Condoms (Rubber Contraceptives)HIS · Traditional | 06/04/1991SE |
Questions and answers
When was OFNat Lubricant (L15) cleared by the FDA?
OFNat Lubricant (L15) (K221243) received a 510(k) decision of Substantially Equivalent on September 30, 2022, 151 days after the submission was received.
What is the product code of K221243?
The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.