TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant
FDA 510(k) K221431 · Church & Dwight Co., Inc.
510(k) numberK221431
Submission
- Device name
- TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant
- Applicant
- Church & Dwight Co., Inc.
Ewing, NJ, US - Received
- May 17, 2022
- Decision date
- July 14, 2022
- 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 |
| K243640 | Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy)HIS · Traditional | Church & Dwight Co., Inc. | 02/21/2025SE |
| 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 |
More from Rb Health (Us), LLC
| 510(k) | Device | Decision |
|---|---|---|
| K243640 | Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy)HIS · Traditional | 02/21/2025SE |
| 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 |
| 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(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant cleared by the FDA?
TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant (K221431) received a 510(k) decision of Substantially Equivalent on July 14, 2022, 58 days after the submission was received.
What is the product code of K221431?
The FDA product code is HIS – Condom, a Class II (moderate risk) device regulated under 21 CFR 884.5300.