Durex Polyisoprene Condom
FDA 510(k) K241617 · Rb Health (Us), LLC
510(k) numberK241617
Submission
- Device name
- Durex Polyisoprene Condom
- Applicant
- Rb Health (Us), LLC
Parsippany, NJ, US - Received
- June 5, 2024
- Decision date
- February 28, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MOL – Condom, Synthetic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5300
- Specialty
- Obstetrics/Gynecology
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|---|---|---|---|
| K252158 | Sagami Original 002 Polyurethane Male CondomMOL · Traditional | Mayer Laboratories | 03/30/2026SE |
| K243967 | ONE Nitrile CondomMOL · Traditional | Global Protection Corp. | 04/08/2025SE |
| K240379 | TROJAN SIS Synthetic Latex Condom with Silicone LubricantMOL · Traditional | Church & Dwight Co., Inc. | 10/08/2024SE |
| K240896 | ONE Nitrile CondomMOL · Traditional | Global Protection Corp. | 08/23/2024SE |
| K232470 | Polyisoprene Extra Large CondomMOL · Abbreviated | Suretex Limited | 05/09/2024SE |
| K231908 | 45 Micron Polyisoprene CondomMOL · Traditional | Suretex Limited | 10/27/2023SE |
| K203541 | Okamoto 002 Lubricated Polyurethane Male CondomMOL · Traditional | Okamoto USA, Inc. | 02/25/2022SE |
| K182438 | Synthetic Polyisoprene Lubricated Male Condom - 5 sensesMOL · Abbreviated | Sxwell USA, LLC | 12/06/2018SE |
| K171172 | Skyn Original Polyisoprene Lubricated Male Condom - FlavoredMOL · Abbreviated | Ansell Healthcare Products, LLC | 08/02/2017SE |
| K171639 | Trojan Supra Lubricated Polyurethane Male CondomMOL · Traditional | Church & Dwight Co., Inc. | 08/01/2017SE |
More from Church & Dwight Co., Inc.
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|---|---|---|
| K230781 | Belle SensilubeNUC · Traditional | 06/20/2023SE |
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| K220489 | Durex Patronus CloseFit, Durex Patronus RegularHIS · Traditional | 11/07/2022SE |
| K222068 | Durex Penck III RegularHIS · Traditional | 10/12/2022SE |
| K211152 | Durex Condom with BenzocaineHIS · Traditional | 05/11/2022SE |
| K213400 | Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play…NUC · Traditional | 03/01/2022SE |
| K213647 | Durex Patronus WideHIS · Traditional | 02/17/2022SE |
| K211088 | Grosz Play FeelNUC · Traditional | 07/09/2021SE |
| K200672 | Durex Penck Standard, Durex Penck XLHIS · Traditional | 11/06/2020SE |
| K201186 | KY Grosz JellyNUC · Traditional | 07/30/2020SE |
Questions and answers
When was Durex Polyisoprene Condom cleared by the FDA?
Durex Polyisoprene Condom (K241617) received a 510(k) decision of Substantially Equivalent on February 28, 2025, 268 days after the submission was received.
What is the product code of K241617?
The FDA product code is MOL – Condom, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 884.5300.