Durex Realfeel Pleasure Gel Personal Lubricant
FDA 510(k) K131643 · Reckitt Benckiser, LLC
510(k) numberK131643
Submission
- Device name
- Durex Realfeel Pleasure Gel Personal Lubricant
- Applicant
- Reckitt Benckiser, LLC
Parsippany, NJ, US - Received
- June 5, 2013
- Decision date
- December 17, 2014
- 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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| K990703 | Sporox II Sterilizing & Disinfecting SolutionMED · Special | 03/30/1999SE |
| K970230 | SporoxMED · Traditional | 10/29/1997SE |
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Questions and answers
When was Durex Realfeel Pleasure Gel Personal Lubricant cleared by the FDA?
Durex Realfeel Pleasure Gel Personal Lubricant (K131643) received a 510(k) decision of Substantially Equivalent on December 17, 2014, 560 days after the submission was received.
What is the product code of K131643?
The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.