FDA device listing
Fashion Seal Healthcare,High Performance Identity,HPI,Superior Uniform Group
FDA device listing 1866819520 · SUPERIOR GROUP OF COMPANIES, INC.
Key facts
| Proprietary names | Fashion Seal Healthcare,High Performance Identity,HPI,Superior Uniform Group |
|---|---|
| Owner/operator | SUPERIOR GROUP OF COMPANIES, INC. |
| Owner/operator number | 9910076 |
| Product codes | FME |
| Device names | FME - Gown, Examination |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6265 |
| Review panels | General Hospital |
| Registered establishments | SUPERIOR GROUP OF COMPANIES, INC., Superior Sourcing |
| Establishment registrations | 2431345, 3017865197 |
| FEI numbers | 1000526042, 3017865197 |
| Establishment operations | Contract Manufacturer, Manufacturer, Specification Developer |
| 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