FDA device listing
Isolation Gown, Lab Coat, Coverall, PE Gown
FDA device listing 1272194600 · ANJI SPENQ INDUSTRIAL CO., LTD.
Key facts
| Proprietary names | Isolation Gown, Lab Coat, Coverall, PE Gown |
|---|---|
| Owner/operator | ANJI SPENQ INDUSTRIAL CO., LTD. |
| Owner/operator number | 10085700 |
| 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 | ANJI SPENQ INDUSTRIAL CO., LTD. |
| Establishment registrations | 3016758972 |
| FEI numbers | 3016758972 |
| Establishment operations | 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