Durex Silicone
FDA 510(k) K143532 · Reckitt Benckiser, LLC
510(k) numberK143532
Submission
- Device name
- Durex Silicone
- Applicant
- Reckitt Benckiser, LLC
Parsippany, NJ, US - Received
- December 12, 2014
- Decision date
- July 31, 2015
- 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.
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| K254101 | Julva Velvé Water-Based Personal LubricantNUC · Traditional | Golden Isles Medical, Inc. | 04/16/2026SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K173504 | K-Y SiliconeNUC · Traditional | 01/12/2018SE |
| K151884 | K-Y Marilyn Pleasure GelNUC · Traditional | 01/11/2016SE |
| K143511 | K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal LubricantNUC · Traditional | 05/20/2015SE |
| K131643 | Durex Realfeel Pleasure Gel Personal LubricantNUC · Traditional | 12/17/2014SE |
| K140193 | Durex Embrace Personal LubricantNUC · Traditional | 11/04/2014SE |
| K990703 | Sporox II Sterilizing & Disinfecting SolutionMED · Special | 03/30/1999SE |
| K970230 | SporoxMED · Traditional | 10/29/1997SE |
| K963353 | Lysol I.C. Brand Phenolic Disinfectant Cleaner (Epa Reg. No. 675-46)LRJ · Traditional | 10/18/1996SE |
Questions and answers
When was Durex Silicone cleared by the FDA?
Durex Silicone (K143532) received a 510(k) decision of Substantially Equivalent on July 31, 2015, 231 days after the submission was received.
What is the product code of K143532?
The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.