Plain Water-based Lubricant
FDA 510(k) K243972 · Global Protection Corp.
510(k) numberK243972
Submission
- Device name
- Plain Water-based Lubricant
- Applicant
- Global Protection Corp.
Boston, MA, US - Received
- December 23, 2024
- Decision date
- August 8, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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.
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| 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 |
|---|---|---|
| K250142 | Water-based LubricantNUC · Traditional | 08/08/2025SE |
| K243967 | ONE Nitrile CondomMOL · Traditional | 04/08/2025SE |
| K240896 | ONE Nitrile CondomMOL · Traditional | 08/23/2024SE |
| K223214 | Powder-Free Nitrile Examination GlovesLZA · Abbreviated | 09/21/2023SE |
| K213087 | Natural Rubber Latex Ultrasound Transducer Probe CoversITX · Traditional | 06/07/2022SE |
| K203536 | Male Latex CondomHIS · Abbreviated | 09/03/2021SE |
| K193578 | Non-spermicidal Lubricated Male Latex CondomHIS · Abbreviated | 08/20/2020SE |
| K024324 | Latex Condom and Latex Condom Lubricated with NONOXYNOL-9HIS · Abbreviated | 03/25/2003SE |
| K960552 | Knight Light Nonlubricated CondomHIS · Traditional | 11/20/1997SE |
Questions and answers
When was Plain Water-based Lubricant cleared by the FDA?
Plain Water-based Lubricant (K243972) received a 510(k) decision of Substantially Equivalent on August 8, 2025, 228 days after the submission was received.
What is the product code of K243972?
The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.