FDA device listing
Non-Reinforced Surgical Gown, L4,Poly-Reinforced Surgical Gown, L4
FDA device listing 1833033942 · NEW YORK EMBROIDERY STUDIO
Key facts
| Proprietary names | Non-Reinforced Surgical Gown, L4,Poly-Reinforced Surgical Gown, L4 |
|---|---|
| Owner/operator | NEW YORK EMBROIDERY STUDIO |
| Owner/operator number | 10073842 |
| Product codes | FYA |
| Device names | FYA - Gown, Surgical |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4040 |
| Review panels | General & Plastic Surgery |
| Registered establishments | New York Embroidery Studio |
| Establishment registrations | 3007088677 |
| FEI numbers | 3007088677 |
| Establishment operations | Contract Manufacturer |
| 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