MOLClass II
Condom, Synthetic
21 CFR 884.5300 / Obstetrics/Gynecology
MOL is the FDA product code for Condom, Synthetic, a class II device type, regulated under 21 CFR 884.5300. As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and 5 recalls.
Classification record
- Product code
- MOL
- Device name
- Condom, Synthetic
- Regulation
- 21 CFR 884.5300
- Device class
- Class II
- Review panel
- Obstetrics/Gynecology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 23
- Ingested recalls
- 5
Clearances, product code MOL
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1995 | 2 |
| 1996 | 2 |
| 1997 | 1 |
| 1998 | 1 |
| 2001 | 1 |
| 2006 | 1 |
| 2008 | 2 |
| 2011 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 3 |
| 2025 | 2 |
| 2026 | 1 |
Applicants with the most clearances
Product code MOL| Applicant | Clearances |
|---|---|
| Church & Dwight Co., Inc. | 4 |
| Ansell Healthcare Products LLC | 3 |
| Carter Products | 2 |
| Global Protection Corp. | 2 |
| Mayer Laboratories | 2 |
| Sensicon Corp. | 2 |
| Suretex, Ltd. | 2 |
| Apex Medical Technologies, Inc. | 1 |
| <Genx> Intl., Inc. | 1 |
| Okamoto U.S.A., Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- CCB Packaging, Inc.
- Church & Dwight Co., Inc.
- Church & Dwight Manufacturing Co., Inc.
- Global Protection Corp.
- Innolatex (Thailand) Limited
- Karex Industries Sdn Bhd
- Lil Drug Store Products, Inc.
- Mayer Laboratories
- Menasha Packaging Company
- Okamoto Industries, Inc.
- Paradise Marketing Services
- Paragon Packaging Incorporated
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.