Condoms (Rubber Contraceptives)
FDA 510(k) K910284 · Suretex, Ltd.
510(k) numberK910284
Submission
- Device name
- Condoms (Rubber Contraceptives)
- Applicant
- Suretex, Ltd.
Avondale, AZ, US - Received
- January 23, 1991
- Decision date
- June 4, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K252521 | LifeStyles® HydraFeel Natural Rubber Latex CondomHIS · Abbreviated | 11/18/2025SE |
| K232470 | Polyisoprene Extra Large CondomMOL · Abbreviated | 05/09/2024SE |
| K231908 | 45 Micron Polyisoprene CondomMOL · Traditional | 10/27/2023SE |
| K232279 | LifeStyles NRL Textured CondomHIS · Abbreviated | 10/05/2023SE |
| K221243 | OFNat Lubricant (L15)NUC · Traditional | 09/30/2022SE |
| K213921 | Microthin Natural Rubber Latex CondomHIS · Abbreviated | 04/28/2022SE |
| K030176 | Lifestyles, Contempo or Private Label-Male Latex Condom with Desensitizing LubricantHIS · Abbreviated | 04/17/2003SE |
| K010371 | Lifestyles, Contempo or Private Label, Male Latex Condom with Glycerine LubricantHIS · Abbreviated | 04/27/2001SE |
| K941258 | Latex CondomHIS · Traditional | 12/06/1995SE |
| K942858 | Latex Condoms W/Spermicidal Lubricant (NONOXYNOL-9)HIS · Traditional | 05/18/1995SE |
Questions and answers
When was Condoms (Rubber Contraceptives) cleared by the FDA?
Condoms (Rubber Contraceptives) (K910284) received a 510(k) decision of Substantially Equivalent on June 4, 1991, 132 days after the submission was received.
What is the product code of K910284?
The FDA product code is HIS – Condom, a Class II (moderate risk) device regulated under 21 CFR 884.5300.