Condom (HIS) contract manufacturers
8 US facilities list FDA product code HIS as a contract manufacturer (5) or contract sterilizer (3).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- Condom
- Product code
- HIS (FDA product classification database)
- Device class
- Class II
- Regulation
- 21 CFR 884.5300
- Classification panel
- Obstetrics and gynecology
Where they are
California 4 · Tennessee 2 · North Carolina 1 · Nevada 1
All 8 facilities
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| BARNETT INTL., CORP. | 1010604 | Contract manufacturer | Obstetrics and gynecology | Stallings, NC | Not verified | Oct 21, 2026 |
| CALATEX, INC. | 2084177 | Contract manufacturer | Obstetrics and gynecology | Santa Ana, CA | Not verified | Oct 21, 2026 |
| CC WELLNESS LLC | 3013395518 | Contract manufacturer | Obstetrics and gynecology | Valencia, CA | Not verified | Oct 21, 2026 |
| DeRoyal Industries, Inc. | 1054241 | Contract sterilizer | General and plastic surgery; General hospital; Gastroenterology and urology +14 more | New Tazewell, TN | Not verified | Oct 21, 2026 |
| DEROYAL INDUSTRIES, INC. | 1055236 | Contract sterilizer | General and plastic surgery; General hospital; Gastroenterology and urology +14 more | New Tazewell, TN | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 2029275 | Contract sterilizer | General and plastic surgery; Orthopedic; Cardiovascular +16 more | Corona, CA | Not verified | Oct 21, 2026 |
| SWG Labs, Inc. dba Trigg Laboratories | 3003963141 | Contract manufacturer | General hospital; Obstetrics and gynecology | Las Vegas, NV | Not verified | Oct 21, 2026 |
| WESTWOOD LABORATORIES, LLC. | 2020372 | Contract manufacturer | Obstetrics and gynecology | Azusa, CA | Not verified | Oct 21, 2026 |
Related obstetrics and gynecology product codes
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- HIF Insufflator, Laparoscopic (24)
- HIH Hysteroscope (And Accessories) (24)
- HGI Electrocautery, Gynecologic (And Accessories) (22)
- NUC Lubricant, Personal (22)
- LKF Cannula, Manipulator/Injector, Uterine (20)
- KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) (16)
- OHM Cesarean Section Tray (14)