TROJAN SIS Synthetic Latex Condom with Silicone Lubricant
FDA 510(k) K240379 · Church & Dwight Co., Inc.
510(k) numberK240379
Submission
- Device name
- TROJAN SIS Synthetic Latex Condom with Silicone Lubricant
- Applicant
- Church & Dwight Co., Inc.
Princeton, NJ, US - Received
- February 7, 2024
- Decision date
- October 8, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MOL – Condom, Synthetic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5300
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code MOL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252158 | Sagami Original 002 Polyurethane Male CondomMOL · Traditional | Mayer Laboratories | 03/30/2026SE |
| K243967 | ONE Nitrile CondomMOL · Traditional | Global Protection Corp. | 04/08/2025SE |
| K241617 | Durex Polyisoprene CondomMOL · Traditional | Rb Health (Us), LLC | 02/28/2025SE |
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K243640 | Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy)HIS · Traditional | 02/21/2025SE |
| K221906 | TROJAN Fire & Ice lubricated male natural rubber latex condomHIS · Traditional | 09/28/2022SE |
| K221431 | TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricantHIS · Traditional | 07/14/2022SE |
| K203818 | Replens Long-Lasting Vaginal MoisturizerNUC · Traditional | 06/11/2021SE |
| K193450 | Pre-Seed Fertility LubricantPEB · Traditional | 07/23/2020SE |
| K180764 | TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)NUC · Traditional | 08/01/2018SE |
| K180104 | Trojan Chain Reaction Natural Rubber Latex Condom with Sensate LubricantHIS · Traditional | 03/14/2018SE |
| K171639 | Trojan Supra Lubricated Polyurethane Male CondomMOL · Traditional | 08/01/2017SE |
| K161915 | Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe LubricantHIS · Traditional | 09/09/2016SE |
| K161544 | Trojan Chain Reaction Personal LubricantNUC · Traditional | 08/31/2016SE |
Questions and answers
When was TROJAN SIS Synthetic Latex Condom with Silicone Lubricant cleared by the FDA?
TROJAN SIS Synthetic Latex Condom with Silicone Lubricant (K240379) received a 510(k) decision of Substantially Equivalent on October 8, 2024, 244 days after the submission was received.
What is the product code of K240379?
The FDA product code is MOL – Condom, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 884.5300.