Data / Medical devices / Condom, Synthetic
Condom, Synthetic (MOL): 9 FDA-registered makers in 5 countries
9 establishments in 5 countries are registered with the FDA to make Condom, Synthetic (product code MOL, Class 2, 21 CFR 884.5300). 7 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 23 510(k) clearances under this code, the latest on March 30, 2026, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MOL
- Device class
- 2
- Regulation
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| Thailand | 3 |
| United States | 3 |
| India | 1 |
| Japan | 1 |
| Malaysia | 1 |
Makers of Condom, Synthetic
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Suretex, Ltd. | Amphur Phunphin Surat Thani, Thailand | Manufacturer | 5 | May 9, 2024 | 0 | 0 | 0 | api.fda.gov |
| Church & Dwight Co., Inc. | Princeton, NJ, United States | Complaint file establishment, Specification developer | 3 | October 8, 2024 | 0 | 0 | 0 | api.fda.gov |
| Global Protection Corp. | Lynn, MA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 3 | April 8, 2025 | 0 | 0 | 0 | api.fda.gov |
| Suretex Prophylactics (India) Private Limited | BANGALORE Karnataka, India | Manufacturer | 3 | October 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| SSL Manufacturing (thailand) Ltd. | BANGSAMAK,BANGPAKONG Chachoengsao, Thailand | Manufacturer, Specification developer | 2 | February 28, 2025 | 0 | 0 | 0 | api.fda.gov |
| Mayer Laboratories | Berkeley, CA, United States | Repackager or relabeler, Specification developer | 1 | October 24, 2001 | 0 | 0 | 0 | api.fda.gov |
| Okamoto Industries, Inc. | Ryugasaki-Shi, Ibaraki-Pref, Japan | Contract manufacturer, Exporter to the US, Manufacturer | 1 | February 25, 2022 | 0 | 0 | 0 | api.fda.gov |
| Innolatex (thailand) Limited | Hat Yai Songkhla, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karex Industries Sdn Bhd | PONTIAN Johor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 30, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.