Lifestyles, Contempo or Private Label, Male Latex Condom with Glycerine Lubricant
FDA 510(k) K010371 · Suretex, Ltd.
510(k) numberK010371
Submission
- Device name
- Lifestyles, Contempo or Private Label, Male Latex Condom with Glycerine Lubricant
- Applicant
- Suretex, Ltd.
Dothan, AL, US - Received
- February 7, 2001
- Decision date
- April 27, 2001
- 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 |
| 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 |
| K941258 | Latex CondomHIS · Traditional | 12/06/1995SE |
| K942858 | Latex Condoms W/Spermicidal Lubricant (NONOXYNOL-9)HIS · Traditional | 05/18/1995SE |
| K910284 | Condoms (Rubber Contraceptives)HIS · Traditional | 06/04/1991SE |
Questions and answers
When was Lifestyles, Contempo or Private Label, Male Latex Condom with Glycerine Lubricant cleared by the FDA?
Lifestyles, Contempo or Private Label, Male Latex Condom with Glycerine Lubricant (K010371) received a 510(k) decision of Substantially Equivalent on April 27, 2001, 79 days after the submission was received.
What is the product code of K010371?
The FDA product code is HIS – Condom, a Class II (moderate risk) device regulated under 21 CFR 884.5300.