FDA device listing
American Dawn Isolation gown
FDA device listing 1361411347 · United Towel Exporters
Key facts
| Proprietary names | American Dawn Isolation gown |
|---|---|
| Owner/operator | United Towel Exporters |
| Owner/operator number | 10047941 |
| Product codes | OEA |
| Device names | OEA - Non-Surgical Gown |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4040 |
| Review panels | General & Plastic Surgery |
| Registered establishments | United towel Exporters |
| Establishment registrations | 3002957587 |
| FEI numbers | 3002957587 |
| Establishment operations | 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