FDA device listing
SEMPERMED SURGEONS' GLOVES - SUPREME
FDA device listing 1692972699 · HARPS Investment Asia Pte. Ltd.
Key facts
| Proprietary names | SEMPERMED SURGEONS' GLOVES - SUPREME |
|---|---|
| Owner/operator | HARPS Investment Asia Pte. Ltd. |
| Owner/operator number | 10045460 |
| Premarket submissions | K981096 |
| Product codes | KGO |
| Device names | KGO - Surgeon'S Gloves |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4460 |
| Review panels | General & Plastic Surgery |
| Registered establishments | HARPS Investment Asia Pte. Ltd. |
| Establishment registrations | 3010605427 |
| FEI numbers | 3010605427 |
| Establishment operations | Foreign Exporter, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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