A garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical
| Company | Devices | Share |
|---|---|---|
| Medline Industries, Inc. | 162 | 32% |
| Lac-Mac Limited | 158 | 32% |
| Standard Textile Co., Inc. | 81 | 16% |
| Novo Health Services, Llc | 51 | 10% |
| Elevate Textiles, Inc. | 20 | 4% |
| Encompass Group, L.L.C. | 18 | 4% |
| Plasdent Corporation | 8 | 2% |
| Sri Healthcare, Llc | 2 | 0% |
Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| FYA | Gown, Surgical | 574 |
| FYA | GOWN, SURGICAL | 217 |
| FRL | Fiber, Medical, Absorbent | 76 |
| OEA | Non-Surgical Isolation Gown | 8 |
| OEA | Non-surgical isolation gown | 6 |
Use these as the dimensions to specify in a tender line.
500 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical gown, reusable", from 8 companies. The largest labeler is Medline Industries, Inc. with 32% of records.
FYA (Gown, Surgical), FYA (GOWN, SURGICAL), FRL (Fiber, Medical, Absorbent), OEA (Non-Surgical Isolation Gown)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.