Trojan Polyurethane Condom (Modification)
FDA 510(k) K955672 · Carter Products
510(k) numberK955672
Submission
- Device name
- Trojan Polyurethane Condom (Modification)
- Applicant
- Carter Products
Cranbury, NJ, US - Received
- November 1, 1995
- Decision date
- August 29, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MOL – Condom, Synthetic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5300
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code MOL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252158 | Sagami Original 002 Polyurethane Male CondomMOL · Traditional | Mayer Laboratories | 03/30/2026SE |
| K243967 | ONE Nitrile CondomMOL · Traditional | Global Protection Corp. | 04/08/2025SE |
| K241617 | Durex Polyisoprene CondomMOL · Traditional | Rb Health (Us), LLC | 02/28/2025SE |
| K240379 | TROJAN SIS Synthetic Latex Condom with Silicone LubricantMOL · Traditional | Church & Dwight Co., Inc. | 10/08/2024SE |
| K240896 | ONE Nitrile CondomMOL · Traditional | Global Protection Corp. | 08/23/2024SE |
| K232470 | Polyisoprene Extra Large CondomMOL · Abbreviated | Suretex Limited | 05/09/2024SE |
| K231908 | 45 Micron Polyisoprene CondomMOL · Traditional | Suretex Limited | 10/27/2023SE |
| K203541 | Okamoto 002 Lubricated Polyurethane Male CondomMOL · Traditional | Okamoto USA, Inc. | 02/25/2022SE |
| K182438 | Synthetic Polyisoprene Lubricated Male Condom - 5 sensesMOL · Abbreviated | Sxwell USA, LLC | 12/06/2018SE |
| K171172 | Skyn Original Polyisoprene Lubricated Male Condom - FlavoredMOL · Abbreviated | Ansell Healthcare Products, LLC | 08/02/2017SE |
More from Ansell Healthcare Products, LLC
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K901201 | Trojan Ribbed Latex Condoms W/Sperm. ModifiedHIS · Traditional | 04/16/1990SE |
| 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 Polyurethane Condom (Modification) cleared by the FDA?
Trojan Polyurethane Condom (Modification) (K955672) received a 510(k) decision of Substantially Equivalent on August 29, 1996, 302 days after the submission was received.
What is the product code of K955672?
The FDA product code is MOL – Condom, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 884.5300.