FDA device listing
Isolation Gown
FDA device listing 1546696386 · Hilo Industries LLC
Key facts
| Proprietary names | Isolation Gown |
|---|---|
| Owner/operator | Hilo Industries LLC |
| Owner/operator number | 10073187 |
| 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 | Hilo Healthcare China Co.,ltd, Hilo Industries LLC |
| Establishment registrations | 3033848619, 3034226814 |
| FEI numbers | 3033848619, 3034226814 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer, Contract 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