FDA device listing
Eikon Cat # 2313-all Dynarex PowderFree Latex Gloves
FDA device listing 1543655722 · Eikon Device Inc.
Key facts
| Proprietary names | Eikon Cat # 2313-all Dynarex PowderFree Latex Gloves |
|---|---|
| Owner/operator | Eikon Device Inc. |
| Owner/operator number | 10044469 |
| Premarket submissions | K970794 |
| Product codes | LYY |
| Device names | LYY - Latex Patient Examination Glove |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6250 |
| Review panels | General Hospital |
| Registered establishments | EIKON DEVICE INC. |
| Establishment registrations | 3010363542 |
| FEI numbers | 3010363542 |
| Establishment operations | Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 10–99 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