Mask, Surgical (FXX) contract manufacturers
14 US facilities list FDA product code FXX as a contract manufacturer (8) or contract sterilizer (6).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- Mask, Surgical
- Product code
- FXX (FDA product classification database)
- Device class
- Class II
- Regulation
- 21 CFR 878.4040
- Classification panel
- General and plastic surgery
Where they are
North Carolina 3 · California 2 · New York 2 · Tennessee 2 · Texas 2 · Georgia 1 · Missouri 1 · Pennsylvania 1
All 14 facilities
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| ANGSTROM MFG., INC. | 3003610374 | Contract manufacturer | Dental; General and plastic surgery; Orthopedic | Sainte Genevieve, MO | Not verified | Oct 21, 2026 |
| BERKLEY MEDICAL RESOURCES, INC. | 2518423 | Contract manufacturer | General and plastic surgery | Smithfield, PA | 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 |
| HEALTHPLUS, LLC | 3018609298 | Contract manufacturer | General and plastic surgery | Asheville, NC | Not verified | Oct 21, 2026 |
| MEXPO INTERNATIONAL, INC. | 2939935 | Contract manufacturer | General hospital; Dental; General and plastic surgery | Union City, CA | Not verified | Oct 21, 2026 |
| New York Embroidery Studio | 3007088677 | Contract manufacturer | General and plastic surgery | Brooklyn, NY | Not verified | Oct 21, 2026 |
| PRESTIGE AMERITECH | 3005022483 | Contract manufacturer | General and plastic surgery; Gastroenterology and urology; Radiology | North Richland Hills, TX | 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 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 |
| SYNTECH, INT'L INC. | 3005142514 | Contract manufacturer | General and plastic surgery | Irvine, CA | Not verified | Oct 21, 2026 |
| United Medical Enterprise, Inc. | 3017949824 | Contract manufacturer | General and plastic surgery; General hospital; Dental | Thomson, GA | Not verified | Oct 21, 2026 |
Related general and plastic surgery product codes
- GEI Electrosurgical, Cutting & Coagulation & Accessories (164)
- FZX Guide, Surgical, Instrument (136)
- MDM Instrument, Manual, Surgical, General Use (130)
- GAD Retractor (113)
- FSM Tray, Surgical, Instrument (106)
- HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment (100)
- FRO Dressing, Wound, Drug (74)
- GEA Cannula, Surgical, General & Plastic Surgery (63)