Trojan Latex Condom with Male Genital Desensitizer Lubricant
FDA 510(k) K000748 · Armkel, LLC
510(k) numberK000748
Submission
- Device name
- Trojan Latex Condom with Male Genital Desensitizer Lubricant
- Applicant
- Armkel, LLC
Cranbury, NJ, US - Received
- March 8, 2000
- Decision date
- April 6, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K040866 | First Response One-Step Digital Pregnancy TestLCX · Traditional | 10/19/2004SE |
| K030258 | First Response Pregnancy TestLCX · Traditional | 02/25/2003SE |
| K023405 | Trojan Mint Tingle Brand Latex CondomsHIS · Abbreviated | 12/16/2002SE |
| K013433 | Trojan Passion Berry GelNUC · Traditional | 03/05/2002SE |
| K013614 | Trojan Crystal Clear LiquidNUC · Traditional | 02/01/2002SE |
| K001212 | Trojan Extra Large Latex CondomHIS · Special | 05/09/2000SE |
| K992232 | First Response 1-STEP PregnancyLCX · Traditional | 12/21/1999SE |
| K973352 | Brand Name *1-STEP PregnancyLCX · Traditional | 10/27/1997SE |
| K973310 | Tbd* One-Step Ovulation Predictor TestCEP · Traditional | 10/27/1997SE |
| K963318 | Legionella Igg/Igm Elisa Test SystemLHL · Traditional | 03/03/1997SE |
Questions and answers
When was Trojan Latex Condom with Male Genital Desensitizer Lubricant cleared by the FDA?
Trojan Latex Condom with Male Genital Desensitizer Lubricant (K000748) received a 510(k) decision of Substantially Equivalent on April 6, 2000, 29 days after the submission was received.
What is the product code of K000748?
The FDA product code is HIS – Condom, a Class II (moderate risk) device regulated under 21 CFR 884.5300.