FDA device listing
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labelling Claim (Black)
FDA device listing 1595606714 · GALLANT QUALITY SDN BHD
Key facts
| Proprietary names | Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labelling Claim (Black) |
|---|---|
| Owner/operator | GALLANT QUALITY SDN BHD |
| Owner/operator number | 9103901 |
| Product codes | LZA |
| Device names | LZA - Polymer Patient Examination Glove |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6250 |
| Review panels | General Hospital |
| Registered establishments | GALLANT QUALITY SDN. BHD. |
| Establishment registrations | 9613998 |
| FEI numbers | 3006581410 |
| Establishment operations | Contract 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