FDA device listing
Surgeon'S Gloves
FDA device listing 1625094246 · GRAND TEN HOLDINGS SDN BHD
Key facts
| Owner/operator | GRAND TEN HOLDINGS SDN BHD |
|---|---|
| Owner/operator number | 10046980 |
| Product codes | KGO, LZC |
| Device names | KGO - Surgeon'S Gloves, LZC - Medical Glove, Specialty |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4460, 880.6250 |
| Review panels | General Hospital, General & Plastic Surgery |
| Registered establishments | GRAND TEN HOLDINGS SDN BHD |
| Establishment registrations | 3010966951 |
| FEI numbers | 3010966951 |
| Establishment operations | Contract Sterilizer |
| 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