FDA product code MOL: Condom, Synthetic
MOL is the FDA product code for condom, synthetic. It is a Class II device, regulated under 21 CFR 884.5300 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 23 510(k) submissions under MOL, 8 in the last five years, from 13 different applicants. The average 510(k) review took 273 days (median 264); 223 days on average over the last three years. FDA has posted 5 recalls for MOL devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Condom, Synthetic |
| Device class | Class II |
| Regulation | 21 CFR 884.5300 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MOL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 82 |
| 2018 | 1 | 90 |
| 2022 | 1 | 449 |
| 2023 | 1 | 120 |
| 2024 | 3 | 218 |
| 2025 | 2 | 187 |
| 2026 | 1 | 264 |
Compare with all 510(k) review times · Search every MOL clearance
Top MOL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Church & Dwight Co., Inc. | 4 | 2024-10-08 |
| Ansell Healthcare Products, LLC | 3 | 2017-08-02 |
| Mayer Laboratories | 2 | 2026-03-30 |
| Global Protection Corp. | 2 | 2025-04-08 |
| Suretex Limited | 2 | 2024-05-09 |
8 more applicants have MOL clearances. See the full list in Caduvo.
Most recent MOL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252158 | Mayer Laboratories | Sagami Original 002 Polyurethane Male Condom | 2026-03-30 | 264 |
| K243967 | Global Protection Corp. | ONE Nitrile Condom | 2025-04-08 | 106 |
| K241617 | Rb Health (Us), LLC | Durex Polyisoprene Condom | 2025-02-28 | 268 |
| K240379 | Church & Dwight Co., Inc. | TROJAN SIS Synthetic Latex Condom with Silicone Lubricant | 2024-10-08 | 244 |
| K240896 | Global Protection Corp. | ONE Nitrile Condom | 2024-08-23 | 144 |
Recalls for MOL devices
5 product recalls in 4 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-06-23.
| Year | Recalls |
|---|---|
| 2018 | 4 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code MOL?
MOL is the FDA product code for condom, synthetic. It is a Class II device, regulated under 21 CFR 884.5300 and reviewed by the Obstetrics and Gynecology panel.
What device class is MOL?
Class II, regulation 21 CFR 884.5300. Typical premarket route: 510(k).
How long does a 510(k) take for product code MOL?
Across 23 cleared submissions the average was 273 days from receipt to decision (median 264).
Which companies have the most MOL clearances?
Church & Dwight Co., Inc. (4); Ansell Healthcare Products, LLC (3); Mayer Laboratories (2); Global Protection Corp. (2); Suretex Limited (2).
Have MOL devices been recalled?
Yes: 5 product recalls across 4 recall events; the most recent began 2022-06-23.
Next steps
- Run an FDA pathway report with predicate devices for product code MOL
- Run a recall and safety report across every MOL manufacturer
- Watch product code MOL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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