MOL — Condom, Synthetic Class II
FDA Device Classification
Classification Details
- Product Code
- MOL
- Device Class
- Class II
- Regulation Number
- 884.5300
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K243967 | global protection | ONE Nitrile Condom | April 8, 2025 |
| K241617 | rb health (us) | Durex Polyisoprene Condom | February 28, 2025 |
| K240379 | church and dwight co | TROJAN SIS Synthetic Latex Condom with Silicone Lubricant | October 8, 2024 |
| K240896 | global protection | ONE Nitrile Condom | August 23, 2024 |
| K232470 | suretex limited | Polyisoprene Extra Large Condom | May 9, 2024 |
| K231908 | suretex limited | 45 Micron Polyisoprene Condom | October 27, 2023 |
| K203541 | okamoto usa | Okamoto 002 Lubricated Polyurethane Male Condom | February 25, 2022 |
| K182438 | sxwell usa | Synthetic Polyisoprene Lubricated Male Condom - 5 senses | December 6, 2018 |
| K171172 | ansell healthcare products | Skyn Original Polyisoprene Lubricated Male Condom - Flavored | August 2, 2017 |
| K171639 | church and dwight co | Trojan Supra Lubricated Polyurethane Male Condom | August 1, 2017 |
| K160399 | ansell healthcare products | Skyn Original Polyisoprene Lubricated Male Condom | July 25, 2016 |
| K100767 | church and dwight co | TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM | April 5, 2011 |
| K072169 | ssl americas | DUREX SYNTHETIC POLYISOPRENE MALE CONDOM | June 19, 2008 |
| K070800 | ansell healthcare products | LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM | March 6, 2008 |
| K050828 | church and dwight co | TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM | February 28, 2006 |
| K001974 | mayer laboratories | EZ-ON CONDOM | October 24, 2001 |
| K974121 | sensicon | LUBRICATED BAGGY TACTYLON CONDOM | January 29, 1998 |
| K971590 | sensicon | TACTYLON CONDOM | October 7, 1997 |
| K962816 | genx intl | SPERM PREPARATION MEDIA | November 26, 1996 |
| K955672 | carter products | TROJAN POLYURETHANE CONDOM (MODIFICATION) | August 29, 1996 |