FDA Product Code
FDA Product Code MOL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.5300
510(k) Clearances — 23 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252158 | Sagami Original 002 Polyurethane Male Condom | Mayer Laboratories | 2026-03-30 | Traditional | PDF ↗ |
| K243967 | ONE Nitrile Condom | Global Protection Corp. | 2025-04-08 | Traditional | PDF ↗ |
| K241617 | Durex Polyisoprene Condom | Rb Health (Us), LLC | 2025-02-28 | Traditional | PDF ↗ |
| K240379 | TROJAN SIS Synthetic Latex Condom with Silicone Lubricant | Church & Dwight Co., Inc. | 2024-10-08 | Traditional | PDF ↗ |
| K240896 | ONE Nitrile Condom | Global Protection Corp. | 2024-08-23 | Traditional | PDF ↗ |
| K232470 | Polyisoprene Extra Large Condom | Suretex Limited | 2024-05-09 | Abbreviated | PDF ↗ |
| K231908 | 45 Micron Polyisoprene Condom | Suretex Limited | 2023-10-27 | Traditional | PDF ↗ |
| K203541 | Okamoto 002 Lubricated Polyurethane Male Condom | Okamoto USA, Inc. | 2022-02-25 | Traditional | PDF ↗ |
| K182438 | Synthetic Polyisoprene Lubricated Male Condom - 5 senses | Sxwell USA, LLC | 2018-12-06 | Abbreviated | PDF ↗ |
| K171172 | Skyn Original Polyisoprene Lubricated Male Condom - Flavored | Ansell Healthcare Products, LLC | 2017-08-02 | Abbreviated | PDF ↗ |
| K171639 | Trojan Supra Lubricated Polyurethane Male Condom | Church & Dwight Co., Inc. | 2017-08-01 | Traditional | PDF ↗ |
| K160399 | Skyn Original Polyisoprene Lubricated Male Condom | Ansell Healthcare Products, LLC | 2016-07-25 | Abbreviated | PDF ↗ |
| K100767 | TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM | Church & Dwight Co., Inc. | 2011-04-05 | Traditional | PDF ↗ |
| K072169 | DUREX SYNTHETIC POLYISOPRENE MALE CONDOM | Ssl Americas, Inc. | 2008-06-19 | Abbreviated | PDF ↗ |
| K070800 | LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM | Ansell Healthcare Products, LLC | 2008-03-06 | Abbreviated | PDF ↗ |
| K050828 | TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM | Church & Dwight Co., Inc. | 2006-02-28 | Traditional | PDF ↗ |
| K001974 | EZ-ON CONDOM | Mayer Laboratories | 2001-10-24 | Traditional | PDF ↗ |
| K974121 | LUBRICATED BAGGY TACTYLON CONDOM | Sensicon Corp. | 1998-01-29 | Traditional | PDF ↗ |
| K971590 | TACTYLON CONDOM | Sensicon Corp. | 1997-10-07 | Traditional | PDF ↗ |
| K962816 | SPERM PREPARATION MEDIA | Genx Intl., Inc. | 1996-11-26 | Traditional | PDF ↗ |
| K955672 | TROJAN POLYURETHANE CONDOM (MODIFICATION) | Carter Products | 1996-08-29 | Traditional | PDF ↗ |
| K942697 | TROJAN POLYURETHANE CONDOM | Carter Products | 1995-06-22 | Traditional | PDF ↗ |
| K922688 | EXTRA PROTECTION POLYURETHANE CONDOM | Apex Medical Technologies, Inc. | 1995-05-04 | Traditional | PDF ↗ |
Product code MOL · Class II · Obstetrics/Gynecology. Data: openFDA.