FDA device listing
6661, Particle Filtering Half Mask FFP3; 6661, Folding Protective Mask KN95 6662, Particle Filtering Half Mask…
FDA device listing 1228132398 · Guangdong golden leaves Technology Development Co., Ltd.
Key facts
| Proprietary names | 6661, Particle Filtering Half Mask FFP3; 6661, Folding Protective Mask KN95 6662, Particle Filtering Half Mask FFP3,6662, Folding Protective Mask KN95 8801, Cup Shape Protective Mask FFP2,8801V, Cup Shape Protective Mask FFP2; 8860, Kids Foldable Protective Mask (Non-Medical),8860, KN95 Disposable Protective Mask; 8861, Folding Protective Mask KN95,8861, Particle Filtering Half Mask FFP2; 8861H… |
|---|---|
| Owner/operator | Guangdong golden leaves Technology Development Co., Ltd. |
| Owner/operator number | 10062979 |
| Product codes | QKR |
| Device names | QKR - Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua |
| Device class | Not classified |
| Classification regulations (21 CFR) | ORCA1.QKR |
| Review panels | General Hospital |
| Registered establishments | GUANGDONG GOLDEN LEAVES TECHNOLOGY DEVELOPMENT CO., LTD. |
| Establishment registrations | 3016635391 |
| FEI numbers | 3016635391 |
| 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