Okamoto 002 Lubricated Polyurethane Male Condom
FDA 510(k) K203541 · Okamoto USA, Inc.
510(k) numberK203541
Submission
- Device name
- Okamoto 002 Lubricated Polyurethane Male Condom
- Applicant
- Okamoto USA, Inc.
Stratford, CT, US - Received
- December 3, 2020
- Decision date
- February 25, 2022
- 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 |
| 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 |
| K171639 | Trojan Supra Lubricated Polyurethane Male CondomMOL · Traditional | Church & Dwight Co., Inc. | 08/01/2017SE |
More from Church & Dwight Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252622 | Male Latex Condom HAHIS · Abbreviated | 05/04/2026SE |
| K243584 | 0.04 ZERO ZERO FOUR Male Latex CondomHIS · Abbreviated | 02/18/2025SE |
| K192669 | Extremely Thin 003, ZERO ZERO THREEHIS · Abbreviated | 07/24/2020SE |
| K141256 | Okamoto Studded CondomHIS · Abbreviated | 07/23/2014SE |
| K140379 | Mega Big Boy CondomHIS · Abbreviated | 07/01/2014SE |
| K090259 | Okamoto Ultra ThinHIS · Abbreviated | 03/31/2009SE |
| K952393 | Okamoto CondomHIS · Traditional | 08/09/1995SE |
| K902804 | Extend Stability Date for Condom W/Sperm LubricantHIS · Traditional | 08/13/1990SE |
| K896339 | Modified Labeling on Okamoto Harmony CondomHIS · Traditional | 01/10/1990SE |
| K884402 | Extra Strength Skin Less Skin CondomHIS · Traditional | 03/10/1989SE |
Questions and answers
When was Okamoto 002 Lubricated Polyurethane Male Condom cleared by the FDA?
Okamoto 002 Lubricated Polyurethane Male Condom (K203541) received a 510(k) decision of Substantially Equivalent on February 25, 2022, 449 days after the submission was received.
What is the product code of K203541?
The FDA product code is MOL – Condom, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 884.5300.