FDA device listing
Lab Coats, Lab Jackets, Protection gowns
FDA device listing 1806325645 · Fomed Industries Inc.
Key facts
| Proprietary names | Lab Coats, Lab Jackets, Protection gowns |
|---|---|
| Owner/operator | Fomed Industries Inc. |
| Owner/operator number | 9010881 |
| Product codes | FXO |
| Device names | FXO - Suit, Surgical |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4040 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Fomed Industries Inc |
| Establishment registrations | 9680887 |
| FEI numbers | 3008439903 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database