Cover, Shoe, Operating-Room (FXP) contract manufacturers
8 US facilities list FDA product code FXP as a contract manufacturer (4) or contract sterilizer (4).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- Cover, Shoe, Operating-Room
- Product code
- FXP (FDA product classification database)
- Device class
- Class I
- Regulation
- 21 CFR 878.4040
- Classification panel
- General and plastic surgery
Where they are
New York 2 · Tennessee 2 · California 1 · North Carolina 1 · Texas 1 · Wisconsin 1
All 8 facilities
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| BIOSEAL | 2027062 | Contract manufacturer | General and plastic surgery; General hospital; Orthopedic +12 more | Placentia, 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 |
| HPK INDUSTRIES | 3023435669 | Contract manufacturer | General and plastic surgery | Frankfort, NY | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 1061124 | Contract sterilizer | General and plastic surgery; Gastroenterology and urology; General hospital +15 more | Charlotte, NC | Not verified | Oct 21, 2026 |
| Sterigenics US LLC | 3004111573 | Contract sterilizer | General and plastic surgery; Gastroenterology and urology; General hospital +15 more | Grand Prairie, TX | Not verified | Oct 21, 2026 |
| TWO ONE TWO NEW YORK, INC. | 3013269506 | Contract manufacturer | General and plastic surgery; General hospital; Radiology | Edgewood, NY | Not verified | Oct 21, 2026 |
| VONCO PRODUCTS, LLC | 1419562 | Contract manufacturer | General hospital; General and plastic surgery | Trevor, WI | Not verified | Oct 21, 2026 |
Related general and plastic surgery product codes
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