Gown, Surgical (FYA) contract manufacturers
18 US facilities list FDA product code FYA as a contract manufacturer (3) or contract sterilizer (15).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- Gown, Surgical
- Product code
- FYA (FDA product classification database)
- Device class
- Class II
- Regulation
- 21 CFR 878.4040
- Classification panel
- General and plastic surgery
Where they are
California 4 · Texas 3 · North Carolina 2 · New York 2 · Tennessee 2 · Georgia 1 · Minnesota 1 · Missouri 1 · New Mexico 1 · Virginia 1
All 18 facilities
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| 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 |
| GREDALE, LLC | 3016711507 | Contract manufacturer | General and plastic surgery | Los Angeles, CA | Not verified | Oct 21, 2026 |
| ISOMEDIX OPERATIONS INC | 1643817 | Contract sterilizer | General and plastic surgery; Gastroenterology and urology; Cardiovascular +14 more | El Paso, TX | Not verified | Oct 21, 2026 |
| Isomedix Operations, Inc | 2032098 | Contract sterilizer | Orthopedic; General and plastic surgery; General hospital +12 more | Ontario, CA | Not verified | Oct 21, 2026 |
| Isomedix Operations, Inc. | 2030624 | Contract sterilizer | Cardiovascular; General and plastic surgery; Gastroenterology and urology +11 more | Temecula, CA | Not verified | Oct 21, 2026 |
| Isomedix Operations, Inc. | 2183744 | Contract sterilizer | Cardiovascular; General and plastic surgery; Gastroenterology and urology +13 more | Minneapolis, MN | Not verified | Oct 21, 2026 |
| MIDWEST STERILIZATION CORP. | 1928237 | Contract sterilizer | General and plastic surgery; Cardiovascular; General hospital +14 more | Jackson, MO | Not verified | Oct 21, 2026 |
| MIDWEST STERILIZATION CORP. | 3005012805 | Contract manufacturer | General and plastic surgery; Gastroenterology and urology; Anesthesiology +12 more | Laredo, TX | Not verified | Oct 21, 2026 |
| New York Embroidery Studio | 3007088677 | Contract manufacturer | General and plastic surgery | Brooklyn, NY | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 1018470 | Contract sterilizer | General and plastic surgery; Orthopedic; General hospital +12 more | Atlanta, GA | 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 U.S., LLC | 1319639 | Contract sterilizer | Cardiovascular; General and plastic surgery; Gastroenterology and urology +14 more | Queensbury, NY | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 1721686 | Contract sterilizer | Cardiovascular; General and plastic surgery; Gastroenterology and urology +6 more | Santa Teresa, NM | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 2029015 | Contract sterilizer | General and plastic surgery; Gastroenterology and urology; General hospital +13 more | Ontario, CA | Not verified | Oct 21, 2026 |
| Sterigenics US LLC | 1058584 | Contract sterilizer | General and plastic surgery; Orthopedic; General hospital +14 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 |
| STERILIZATION SERVICES OF VIRGINIA | 1123137 | Contract sterilizer | General and plastic surgery; Cardiovascular; General hospital +9 more | Richmond, VA | Not verified | Oct 21, 2026 |
Related general and plastic surgery product codes
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- FZX Guide, Surgical, Instrument (136)
- MDM Instrument, Manual, Surgical, General Use (130)
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- FSM Tray, Surgical, Instrument (106)
- HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment (100)
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