FDA device listing
gowns,coverall,medical gown,Isolation Gowns,protection grown/coverall,lab coat,patient cloth,Non-Surgical Isolation Gown
FDA device listing 1413457512 · RIZHAO SANQI MEDICAL & HEALTH ARTICLES CO., LTD
Key facts
| Proprietary names | gowns,coverall,medical gown,Isolation Gowns,protection grown/coverall,lab coat,patient cloth,Non-Surgical Isolation Gown |
|---|---|
| Owner/operator | RIZHAO SANQI MEDICAL & HEALTH ARTICLES CO., LTD |
| Owner/operator number | 10044543 |
| 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 | RIZHAO SANQI MEDICAL & HEALTH ARTICLES CO., LTD |
| Establishment registrations | 3010374972 |
| FEI numbers | 3010374972 |
| 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