FDA device listing
Non-Surgical Isolation Gowns
FDA device listing 1362385843 · Sigmatex, Inc. d/b/a/ Sigmatex-Lanier Textiles
Key facts
| Proprietary names | Non-Surgical Isolation Gowns |
|---|---|
| Owner/operator | Sigmatex, Inc. d/b/a/ Sigmatex-Lanier Textiles |
| Owner/operator number | 10075645 |
| Product codes | OEA |
| Device names | OEA - Non-Surgical Gown |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4040 |
| Review panels | General & Plastic Surgery |
| Registered establishments | SIGMATEX, INC. D/B/A/ SIGMATEX-LANIER TEXTILES |
| Establishment registrations | 1000521459 |
| FEI numbers | 1000521459 |
| Establishment operations | Complaint File Establishment |
| 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