Kimono Microthin
FDA 510(k) K946374 · Mayer Laboratories
510(k) numberK946374
Submission
- Device name
- Kimono Microthin
- Applicant
- Mayer Laboratories
Oakland, CA, US - Received
- December 14, 1994
- Decision date
- November 8, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K252158 | Sagami Original 002 Polyurethane Male CondomMOL · Traditional | 03/30/2026SE |
| K130345 | Aqua Lube Natural Lubricant - Regular, WarmingNUC · Traditional | 08/01/2013SE |
| K113686 | Kimono Microthin with Aqua Lube, Reality Ultra LubricatedHIS · Abbreviated | 03/06/2012SE |
| K110325 | Aqua LubeNUC · Traditional | 12/08/2011SE |
| K001974 | Ez-On CondomMOL · Traditional | 10/24/2001SE |
| K946376 | MaxxHIS · Traditional | 09/22/1995SE |
| K943064 | Kimono (Condoms)HIS · Traditional | 09/22/1995SE |
| K925869 | Sheathes, Sterile SheathesITX · Traditional | 01/06/1994SE |
| K926049 | Digitex, Digitex HypoallergenicLYY · Traditional | 07/22/1993SE |
| K904375 | Kimono PlusHIS · Traditional | 11/26/1990SE |
Questions and answers
When was Kimono Microthin cleared by the FDA?
Kimono Microthin (K946374) received a 510(k) decision of Substantially Equivalent on November 8, 1995, 329 days after the submission was received.
What is the product code of K946374?
The FDA product code is HIS – Condom, a Class II (moderate risk) device regulated under 21 CFR 884.5300.