0.04 ZERO ZERO FOUR Male Latex Condom
FDA 510(k) K243584 · Okamoto USA, Inc.
510(k) numberK243584
Submission
- Device name
- 0.04 ZERO ZERO FOUR Male Latex Condom
- Applicant
- Okamoto USA, Inc.
Sandusky, OH, US - Received
- November 20, 2024
- Decision date
- February 18, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
| 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 |
| K222068 | Durex Penck III RegularHIS · Traditional | Rb Health (Us), LLC | 10/12/2022SE |
More from Rb Health (Us), LLC
| 510(k) | Device | Decision |
|---|---|---|
| K252622 | Male Latex Condom HAHIS · Abbreviated | 05/04/2026SE |
| K203541 | Okamoto 002 Lubricated Polyurethane Male CondomMOL · Traditional | 02/25/2022SE |
| 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 0.04 ZERO ZERO FOUR Male Latex Condom cleared by the FDA?
0.04 ZERO ZERO FOUR Male Latex Condom (K243584) received a 510(k) decision of Substantially Equivalent on February 18, 2025, 90 days after the submission was received.
What is the product code of K243584?
The FDA product code is HIS – Condom, a Class II (moderate risk) device regulated under 21 CFR 884.5300.