FDA device listing
Surgical mask/KN95 mask/Civilian face mask/facemask Medical mask/Medical mask
FDA device listing 1022620790 · Jiangsu Hongsheng Bioengineering Co., Ltd.
Key facts
| Proprietary names | Surgical mask/KN95 mask/Civilian face mask/facemask Medical mask/Medical mask |
|---|---|
| Owner/operator | Jiangsu Hongsheng Bioengineering Co., Ltd. |
| Owner/operator number | 10091766 |
| Product codes | KHA |
| Device names | KHA - Mask, Scavenging |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.5590 |
| Review panels | Anesthesiology |
| Registered establishments | Jiangsu Hongsheng Bioengineering Co., Ltd. |
| Establishment registrations | 3033858895 |
| FEI numbers | 3033858895 |
| 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