FDA device listing
Coverall,isolation gown
FDA device listing 1130137510 · HUBEI KIMSOUL INDUSTRIAL CO.,LTD
Key facts
| Proprietary names | Coverall,isolation gown |
|---|---|
| Owner/operator | HUBEI KIMSOUL INDUSTRIAL CO.,LTD |
| Owner/operator number | 10066643 |
| 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 | HUBEI KIMSOUL INDUSTRIAL CO.,LTD |
| Establishment registrations | 3014198412 |
| FEI numbers | 3014198412 |
| Establishment operations | Foreign Exporter, Manufacturer, Remanufacturer, Repackager/Relabeler, Reprocessor of Single Use Devices |
| 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