Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy)
FDA 510(k) K243640 · Church & Dwight Co., Inc.
510(k) numberK243640
Submission
- Device name
- Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy)
- Applicant
- Church & Dwight Co., Inc.
Ewing, NJ, US - Received
- November 25, 2024
- Decision date
- February 21, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HIS – Condom
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5300
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HIS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252622 | Male Latex Condom HAHIS · Abbreviated | Okamoto USA, Inc. | 05/04/2026SE |
| K252521 | LifeStyles® HydraFeel Natural Rubber Latex CondomHIS · Abbreviated | Suretex Limited | 11/18/2025SE |
| K250034 | Natural rubber latex male condomHIS · Traditional | Shaoguan Regenex Pharmaceuticals Co., Ltd. | 07/11/2025SE |
| K243421 | Lelo Hex Lubricated Natural Rubber Latex CondomHIS · Traditional | Lelo, Inc. | 03/07/2025SE |
| K243584 | 0.04 ZERO ZERO FOUR Male Latex CondomHIS · Abbreviated | Okamoto USA, Inc. | 02/18/2025SE |
| K232279 | LifeStyles NRL Textured CondomHIS · Abbreviated | Suretex Limited | 10/05/2023SE |
| K230049 | SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots…HIS · Traditional | Ttk Healthcare Limited | 09/07/2023SE |
| K222611 | Male Latex CondomsHIS · Traditional | Suzhou Colour-Way New Material Co., Ltd. | 11/28/2022SE |
| K220489 | Durex Patronus CloseFit, Durex Patronus RegularHIS · Traditional | Rb Health (Us), LLC | 11/07/2022SE |
| K222068 | Durex Penck III RegularHIS · Traditional | Rb Health (Us), LLC | 10/12/2022SE |
More from Rb Health (Us), LLC
| 510(k) | Device | Decision |
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| K240379 | TROJAN SIS Synthetic Latex Condom with Silicone LubricantMOL · Traditional | 10/08/2024SE |
| 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 Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy) cleared by the FDA?
Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy) (K243640) received a 510(k) decision of Substantially Equivalent on February 21, 2025, 88 days after the submission was received.
What is the product code of K243640?
The FDA product code is HIS – Condom, a Class II (moderate risk) device regulated under 21 CFR 884.5300.