Synthetic Polyisoprene Lubricated Male Condom - 5 senses
FDA 510(k) K182438 · Sxwell USA, LLC
510(k) numberK182438
Submission
- Device name
- Synthetic Polyisoprene Lubricated Male Condom - 5 senses
- Applicant
- Sxwell USA, LLC
Iselin, NJ, US - Received
- September 7, 2018
- Decision date
- December 6, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
| K231908 | 45 Micron Polyisoprene CondomMOL · Traditional | Suretex Limited | 10/27/2023SE |
| K203541 | Okamoto 002 Lubricated Polyurethane Male CondomMOL · Traditional | Okamoto USA, Inc. | 02/25/2022SE |
| 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 |
|---|---|---|
| K172473 | LifeStyles® SKYN® Intimate Moments Personal LubricantNUC · Traditional | 12/15/2017SE |
Questions and answers
When was Synthetic Polyisoprene Lubricated Male Condom - 5 senses cleared by the FDA?
Synthetic Polyisoprene Lubricated Male Condom - 5 senses (K182438) received a 510(k) decision of Substantially Equivalent on December 6, 2018, 90 days after the submission was received.
What is the product code of K182438?
The FDA product code is MOL – Condom, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 884.5300.