Ez-On Condom
FDA 510(k) K001974 · Mayer Laboratories
510(k) numberK001974
Submission
- Device name
- Ez-On Condom
- Applicant
- Mayer Laboratories
Oakland, CA, US - Received
- June 29, 2000
- Decision date
- October 24, 2001
- 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 |
| 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 |
| 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 |
More from Ansell Healthcare Products, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K252158 | Sagami Original 002 Polyurethane Male CondomMOL · Traditional | 03/30/2026SE |
| K130345 | Aqua Lube Natural Lubricant - Regular, WarmingNUC · Traditional | 08/01/2013SE |
| K113686 | Kimono Microthin with Aqua Lube, Reality Ultra LubricatedHIS · Abbreviated | 03/06/2012SE |
| K110325 | Aqua LubeNUC · Traditional | 12/08/2011SE |
| K946374 | Kimono MicrothinHIS · Traditional | 11/08/1995SE |
| K946376 | MaxxHIS · Traditional | 09/22/1995SE |
| K943064 | Kimono (Condoms)HIS · Traditional | 09/22/1995SE |
| K925869 | Sheathes, Sterile SheathesITX · Traditional | 01/06/1994SE |
| K926049 | Digitex, Digitex HypoallergenicLYY · Traditional | 07/22/1993SE |
| K904375 | Kimono PlusHIS · Traditional | 11/26/1990SE |
Questions and answers
When was Ez-On Condom cleared by the FDA?
Ez-On Condom (K001974) received a 510(k) decision of Substantially Equivalent on October 24, 2001, 482 days after the submission was received.
What is the product code of K001974?
The FDA product code is MOL – Condom, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 884.5300.