FDA device listing
Molnlycke (VL,KK) - Biogel Skinsense
FDA device listing 1421027713 · STERIS Corporation
Key facts
| Proprietary names | Molnlycke (VL,KK) - Biogel Skinsense |
|---|---|
| Owner/operator | STERIS Corporation |
| Owner/operator number | 10042227 |
| 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 | Synergy Health Ede BV, Synergy Sterilisation (M) Sdn Bhd |
| Establishment registrations | 3009337401, 3010220595 |
| FEI numbers | 3009337401, 3010220595 |
| 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