Panels › Obstetrics/Gynecology › Product code MOL · Class 2
Condom, Synthetic
Regulation 884.5300
1510(k)s in 12 months (23 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in MOL
| Company | 510(k)s | Recalls |
|---|---|---|
| Church & Dwight Co., Inc. | 4 | 0 |
| Reckitt Benckiser LLC | 0 | 4 |
| Ansell Healthcare Products, LLC | 3 | 0 |
| Carter Products | 2 | 0 |
| Global Protection Corp. | 2 | 0 |
| Mayer Laboratories | 2 | 0 |
| Sensicon Corp. | 2 | 0 |
| Suretex Limited | 2 | 0 |
| Apex Medical Technologies, Inc. | 1 | 0 |
| Family Dollar Stores, Llc. | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 30, 2026 | K252158 | Sagami Original 002 Polyurethane Male Condom Mayer Laboratories | MOL |
| Apr 8, 2025 | K243967 | ONE Nitrile Condom Global Protection Corp. | MOL |
| Feb 28, 2025 | K241617 | Durex Polyisoprene Condom Rb Health (Us), LLC | MOL |
| Oct 8, 2024 | K240379 | TROJAN SIS Synthetic Latex Condom with Silicone Lubricant Church & Dwight Co., Inc. | MOL |
| Aug 23, 2024 | K240896 | ONE Nitrile Condom Global Protection Corp. | MOL |
| May 9, 2024 | K232470 | Polyisoprene Extra Large Condom Suretex Limited, TH | MOL |
| Oct 27, 2023 | K231908 | 45 Micron Polyisoprene Condom Suretex Limited, TH | MOL |
| Feb 25, 2022 | K203541 | Okamoto 002 Lubricated Polyurethane Male Condom Okamoto USA, Inc. | MOL |
| Dec 6, 2018 | K182438 | Synthetic Polyisoprene Lubricated Male Condom - 5 senses Sxwell USA, LLC | MOL |
| Aug 2, 2017 | K171172 | Skyn Original Polyisoprene Lubricated Male Condom - Flavored Ansell Healthcare Products, LLC | MOL |
| Aug 1, 2017 | K171639 | Trojan Supra Lubricated Polyurethane Male Condom Church & Dwight Co., Inc. | MOL |
| Jul 25, 2016 | K160399 | Skyn Original Polyisoprene Lubricated Male Condom Ansell Healthcare Products, LLC | MOL |
| Apr 5, 2011 | K100767 | TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM Church & Dwight Co., Inc. | MOL |
| Jun 19, 2008 | K072169 | DUREX SYNTHETIC POLYISOPRENE MALE CONDOM Ssl Americas, Inc. | MOL |
| Mar 6, 2008 | K070800 | LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM Ansell Healthcare Products, LLC | MOL |
| Feb 28, 2006 | K050828 | TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM Church & Dwight Co., Inc. | MOL |
| Oct 24, 2001 | K001974 | EZ-ON CONDOM Mayer Laboratories | MOL |
| Jan 29, 1998 | K974121 | LUBRICATED BAGGY TACTYLON CONDOM Sensicon Corp. | MOL |
| Oct 7, 1997 | K971590 | TACTYLON CONDOM Sensicon Corp. | MOL |
| Nov 26, 1996 | K962816 | SPERM PREPARATION MEDIA Genx Intl., Inc. | MOL |
| Aug 29, 1996 | K955672 | TROJAN POLYURETHANE CONDOM (MODIFICATION) Carter Products | MOL |
| Jun 22, 1995 | K942697 | TROJAN POLYURETHANE CONDOM Carter Products | MOL |
| May 4, 1995 | K922688 | EXTRA PROTECTION POLYURETHANE CONDOM Apex Medical Technologies, Inc. | MOL |
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