Data / Medical devices / Condom / United States
FDA-registered makers of Condom in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Condom (product code HIS). 10 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Condom
- Product code
- HIS
- Country
- United States
Makers of Condom in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Church & Dwight Co., Inc. | Princeton, NJ, United States | Complaint file establishment, Specification developer | 23 | May 4, 2026 | 0 | 0 | 0 | api.fda.gov |
| Church & Dwight Manufacturing Co., Inc. | South Chesterfield, VA, United States | Manufacturer, Manufacturer for export, Repackager or relabeler | 19 | May 4, 2026 | 0 | 0 | 0 | api.fda.gov |
| Global Protection Corp. | Lynn, MA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 18 | February 21, 2025 | 0 | 1 | 0 | api.fda.gov |
| Mayer Laboratories | Berkeley, CA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 11 | September 23, 2021 | 0 | 0 | 0 | api.fda.gov |
| Davryan Laboratories, Inc. | Valparaiso, IN, United States | Specification developer | 2 | November 22, 1995 | 0 | 0 | 0 | api.fda.gov |
| WESTRIDGE LABORATORIES, Inc | Santa Ana, CA, United States | Specification developer | 2 | May 1, 2014 | 0 | 0 | 0 | api.fda.gov |
| Apex Medical Technologies, Inc. | San Diego, CA, United States | Complaint file establishment, Manufacturer | 1 | January 5, 1996 | 0 | 0 | 0 | api.fda.gov |
| Calatex, Inc. | Santa Ana, CA, United States | Specification developer | 1 | August 14, 2015 | 0 | 0 | 0 | api.fda.gov |
| SWG Labs, Inc. dba Trigg Laboratories | Las Vegas, NV, United States | Contract manufacturer, Manufacturer | 1 | December 13, 2001 | 0 | 0 | 0 | api.fda.gov |
| Utah Medical Products, Inc. | Midvale, UT, United States | Manufacturer | 1 | May 9, 1991 | 0 | 0 | 0 | api.fda.gov |
| Barnett Intl., Corp. | Stallings, NC, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| CC Wellness LLC | Valencia, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Westwood Laboratories, LLC. | Azusa, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.