TROJAN Fire & Ice lubricated male natural rubber latex condom
FDA 510(k) K221906 · Church & Dwight Co., Inc.
510(k) numberK221906
Submission
- Device name
- TROJAN Fire & Ice lubricated male natural rubber latex condom
- Applicant
- Church & Dwight Co., Inc.
Ewing, NJ, US - Received
- June 30, 2022
- Decision date
- September 28, 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 |
| 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 Fire & Ice lubricated male natural rubber latex condom cleared by the FDA?
TROJAN Fire & Ice lubricated male natural rubber latex condom (K221906) received a 510(k) decision of Substantially Equivalent on September 28, 2022, 90 days after the submission was received.
What is the product code of K221906?
The FDA product code is HIS – Condom, a Class II (moderate risk) device regulated under 21 CFR 884.5300.