FDA device listing
Disposable apron,Emergency PPE Kit,Eye protection/Safety glasses,Face Shield,Full Body Protection Ensemble,Hand…
FDA device listing 1525145637 · Rusun Medical Co., Ltd
Key facts
| Proprietary names | Disposable apron,Emergency PPE Kit,Eye protection/Safety glasses,Face Shield,Full Body Protection Ensemble,Hand sanitizer kit,Head cover/Surgical cap,Medical gloves (nitrile),N95 respiratory mask,PPE Disposal bag,Protective gown,Protective sleeve covers,Shoe covers,Sterile surgical gloves,Surgical apparel,Tactical Operator PPE Kit |
|---|---|
| Owner/operator | Rusun Medical Co., Ltd |
| Owner/operator number | 10085490 |
| Product codes | LYU |
| Device names | LYU - Accessory, Surgical Apparel |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4040 |
| Review panels | General & Plastic Surgery |
| Registered establishments | RUSUN MEDICAL CO., LTD |
| Establishment registrations | 3023809973 |
| FEI numbers | 3023809973 |
| 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