Durex Penck III Regular
FDA 510(k) K222068 · Rb Health (Us), LLC
510(k) numberK222068
Submission
- Device name
- Durex Penck III Regular
- Applicant
- Rb Health (Us), LLC
Parsippany, NJ, US - Received
- July 14, 2022
- Decision date
- October 12, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K241617 | Durex Polyisoprene CondomMOL · Traditional | 02/28/2025SE |
| K230781 | Belle SensilubeNUC · Traditional | 06/20/2023SE |
| K213892 | Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & MineNUC · Traditional | 03/07/2023SE |
| K220489 | Durex Patronus CloseFit, Durex Patronus RegularHIS · Traditional | 11/07/2022SE |
| K211152 | Durex Condom with BenzocaineHIS · Traditional | 05/11/2022SE |
| K213400 | Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play…NUC · Traditional | 03/01/2022SE |
| K213647 | Durex Patronus WideHIS · Traditional | 02/17/2022SE |
| K211088 | Grosz Play FeelNUC · Traditional | 07/09/2021SE |
| K200672 | Durex Penck Standard, Durex Penck XLHIS · Traditional | 11/06/2020SE |
| K201186 | KY Grosz JellyNUC · Traditional | 07/30/2020SE |
Questions and answers
When was Durex Penck III Regular cleared by the FDA?
Durex Penck III Regular (K222068) received a 510(k) decision of Substantially Equivalent on October 12, 2022, 90 days after the submission was received.
What is the product code of K222068?
The FDA product code is HIS – Condom, a Class II (moderate risk) device regulated under 21 CFR 884.5300.