Trojan Ribbed Latex Condoms W/Sperm. Modified
FDA 510(k) K901201 · Carter Products
510(k) numberK901201
Submission
- Device name
- Trojan Ribbed Latex Condoms W/Sperm. Modified
- Applicant
- Carter Products
Cranbury, NJ, US - Received
- March 12, 1990
- Decision date
- April 16, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K955672 | Trojan Polyurethane Condom (Modification)MOL · Traditional | 08/29/1996SE |
| K942697 | Trojan Polyurethane CondomMOL · Traditional | 06/22/1995SE |
| K912901 | Trojan (Tm-Tbd) CondomHIS · Traditional | 02/03/1992SE |
| K904782 | Answer Quick and Simple At-Home Pregnancy TestLCX · Traditional | 12/06/1990SE |
| K904273 | Magnum Plus Latex Condoms with Spermicidal Lub.LTZ · Traditional | 10/31/1990SE |
| K901202 | Trojan Naturalamb Lubricated Natural ModifiedHIS · Traditional | 06/19/1990SE |
| K901200 | Trojan for Women Latex Condoms W/Spermi. ModifiedHIS · Traditional | 04/16/1990SE |
| K901199 | Trojan-Enz Latex Condoms W/Spermicidal ModifiedHIS · Traditional | 04/16/1990SE |
| K901198 | Trojan Plus 2 Latex Condoms W/Spermicidal ModifiedHIS · Traditional | 04/16/1990SE |
| K901197 | Trojan Extra Strength Lubri. Condoms Modi. LabelHIS · Traditional | 04/16/1990SE |
Questions and answers
When was Trojan Ribbed Latex Condoms W/Sperm. Modified cleared by the FDA?
Trojan Ribbed Latex Condoms W/Sperm. Modified (K901201) received a 510(k) decision of Substantially Equivalent on April 16, 1990, 35 days after the submission was received.
What is the product code of K901201?
The FDA product code is HIS – Condom, a Class II (moderate risk) device regulated under 21 CFR 884.5300.