Product code MOL
- Device name
- Condom, Synthetic
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.5300
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252158 | Sagami Original 002 Polyurethane Male Condom | Mayer Laboratories | 2026-03-30 |
| K243967 | ONE Nitrile Condom | Global Protection Corp. | 2025-04-08 |
| K241617 | Durex Polyisoprene Condom | Rb Health (Us), LLC | 2025-02-28 |
| K240379 | TROJAN SIS Synthetic Latex Condom with Silicone Lubricant | Church & Dwight Co., Inc. | 2024-10-08 |
| K240896 | ONE Nitrile Condom | Global Protection Corp. | 2024-08-23 |
| K232470 | Polyisoprene Extra Large Condom | Suretex Limited | 2024-05-09 |
| K231908 | 45 Micron Polyisoprene Condom | Suretex Limited | 2023-10-27 |
| K203541 | Okamoto 002 Lubricated Polyurethane Male Condom | Okamoto USA, Inc. | 2022-02-25 |
| K182438 | Synthetic Polyisoprene Lubricated Male Condom - 5 senses | Sxwell USA, LLC | 2018-12-06 |
| K171172 | Skyn Original Polyisoprene Lubricated Male Condom - Flavored | Ansell Healthcare Products, LLC | 2017-08-02 |
| K171639 | Trojan Supra Lubricated Polyurethane Male Condom | Church & Dwight Co., Inc. | 2017-08-01 |
| K160399 | Skyn Original Polyisoprene Lubricated Male Condom | Ansell Healthcare Products, LLC | 2016-07-25 |
| K100767 | TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM | Church & Dwight Co., Inc. | 2011-04-05 |
| K072169 | DUREX SYNTHETIC POLYISOPRENE MALE CONDOM | Ssl Americas, Inc. | 2008-06-19 |
| K070800 | LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM | Ansell Healthcare Products, LLC | 2008-03-06 |
| K050828 | TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM | Church & Dwight Co., Inc. | 2006-02-28 |
| K001974 | EZ-ON CONDOM | Mayer Laboratories | 2001-10-24 |
| K974121 | LUBRICATED BAGGY TACTYLON CONDOM | Sensicon Corp. | 1998-01-29 |
| K971590 | TACTYLON CONDOM | Sensicon Corp. | 1997-10-07 |
| K962816 | SPERM PREPARATION MEDIA | Genx Intl., Inc. | 1996-11-26 |
| K955672 | TROJAN POLYURETHANE CONDOM (MODIFICATION) | Carter Products | 1996-08-29 |
| K942697 | TROJAN POLYURETHANE CONDOM | Carter Products | 1995-06-22 |
| K922688 | EXTRA PROTECTION POLYURETHANE CONDOM | Apex Medical Technologies, Inc. | 1995-05-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08859798100612 | SKYN | SURETEX LIMITED - BRANCH | 2023-09-18 |
| 08859798100452 | SKYN | SURETEX LIMITED - BRANCH | 2023-09-15 |
| 08859798100445 | SKYN | SURETEX LIMITED - BRANCH | 2023-09-15 |
| 08859798100438 | SKYN | SURETEX LIMITED - BRANCH | 2023-09-15 |
| 08859798100421 | SKYN | SURETEX LIMITED - BRANCH | 2023-09-15 |
| 08859798100414 | SKYN | SURETEX LIMITED - BRANCH | 2023-09-15 |
| 08859798100407 | SKYN | SURETEX LIMITED - BRANCH | 2023-09-15 |
| 08859798100391 | SKYN | SURETEX LIMITED - BRANCH | 2023-09-15 |
| 08859798100230 | SKYN | SURETEX LIMITED - BRANCH | 2023-09-14 |
| 08859798100384 | SKYN | SURETEX LIMITED - BRANCH | 2023-09-14 |
| 08859798100315 | SKYN | SURETEX LIMITED - BRANCH | 2023-09-14 |
| 08859798100278 | SKYN | SURETEX LIMITED - BRANCH | 2023-09-14 |
| 08859798100261 | SKYN | SURETEX LIMITED - BRANCH | 2023-09-14 |
| 08859798100254 | SKYN | SURETEX LIMITED - BRANCH | 2023-09-14 |
| 08859798100247 | SKYN | SURETEX LIMITED - BRANCH | 2023-09-14 |
| 08859798100223 | SKYN | SURETEX LIMITED - BRANCH | 2023-09-14 |
| 08859798100216 | SKYN | SURETEX LIMITED - BRANCH | 2023-09-14 |
| 08859798100209 | SKYN | SURETEX LIMITED - BRANCH | 2023-09-14 |
| 08859798100193 | SKYN | SURETEX LIMITED - BRANCH | 2023-09-14 |
| 08859798100186 | SKYN | SURETEX LIMITED - BRANCH | 2023-09-14 |
| 08859798100179 | SKYN | SURETEX LIMITED - BRANCH | 2023-09-14 |
| 08859798100162 | SKYN | SURETEX LIMITED - BRANCH | 2023-09-14 |
| 08859798100155 | SKYN | SURETEX LIMITED - BRANCH | 2023-09-14 |
| 08859798100148 | SKYN | SURETEX LIMITED - BRANCH | 2023-09-14 |
| 08859798100131 | SKYN | SURETEX LIMITED - BRANCH | 2023-09-14 |
| 08859798100124 | SKYN | SURETEX LIMITED - BRANCH | 2023-09-14 |
| 08859798100049 | SKYN | SURETEX LIMITED - BRANCH | 2023-09-14 |
| 08859798100032 | SKYN | SURETEX LIMITED - BRANCH | 2023-09-14 |
| 08859798100025 | SKYN | SURETEX LIMITED - BRANCH | 2023-09-14 |
| 08859798100018 | SKYN | SURETEX LIMITED - BRANCH | 2023-09-07 |