45 Micron Polyisoprene Condom
FDA 510(k) K231908 · Suretex Limited
510(k) numberK231908
Submission
- Device name
- 45 Micron Polyisoprene Condom
- Applicant
- Suretex Limited
Tambon Khao Kwai, Amphur Phunphin, TH - Received
- June 29, 2023
- Decision date
- October 27, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MOL – Condom, Synthetic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5300
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code MOL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252158 | Sagami Original 002 Polyurethane Male CondomMOL · Traditional | Mayer Laboratories | 03/30/2026SE |
| K243967 | ONE Nitrile CondomMOL · Traditional | Global Protection Corp. | 04/08/2025SE |
| K241617 | Durex Polyisoprene CondomMOL · Traditional | Rb Health (Us), LLC | 02/28/2025SE |
| K240379 | TROJAN SIS Synthetic Latex Condom with Silicone LubricantMOL · Traditional | Church & Dwight Co., Inc. | 10/08/2024SE |
| K240896 | ONE Nitrile CondomMOL · Traditional | Global Protection Corp. | 08/23/2024SE |
| K232470 | Polyisoprene Extra Large CondomMOL · Abbreviated | Suretex Limited | 05/09/2024SE |
| K203541 | Okamoto 002 Lubricated Polyurethane Male CondomMOL · Traditional | Okamoto USA, Inc. | 02/25/2022SE |
| K182438 | Synthetic Polyisoprene Lubricated Male Condom - 5 sensesMOL · Abbreviated | Sxwell USA, LLC | 12/06/2018SE |
| K171172 | Skyn Original Polyisoprene Lubricated Male Condom - FlavoredMOL · Abbreviated | Ansell Healthcare Products, LLC | 08/02/2017SE |
| K171639 | Trojan Supra Lubricated Polyurethane Male CondomMOL · Traditional | Church & Dwight Co., Inc. | 08/01/2017SE |
More from Church & Dwight Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252521 | LifeStyles® HydraFeel Natural Rubber Latex CondomHIS · Abbreviated | 11/18/2025SE |
| K232470 | Polyisoprene Extra Large CondomMOL · Abbreviated | 05/09/2024SE |
| 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 |
| K910284 | Condoms (Rubber Contraceptives)HIS · Traditional | 06/04/1991SE |
Questions and answers
When was 45 Micron Polyisoprene Condom cleared by the FDA?
45 Micron Polyisoprene Condom (K231908) received a 510(k) decision of Substantially Equivalent on October 27, 2023, 120 days after the submission was received.
What is the product code of K231908?
The FDA product code is MOL – Condom, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 884.5300.