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 |
|---|---|---|
| Gri Medical & Electronic Technology Co., Ltd. | 451 | 24% |
| Medline Industries, Inc. | 255 | 14% |
| O&M Halyard, Inc. | 236 | 13% |
| Cardinal Health 200, Llc | 147 | 8% |
| Stryker Corporation | 114 | 6% |
| Foshan Nanhai Plus Medical Co., Ltd | 96 | 5% |
| Alpha Pro Tech, Inc. | 95 | 5% |
| Plasdent Corporation | 33 | 2% |
| Medtecs (Taiwan) Corp. | 32 | 2% |
| Avanos Medical, Inc. | 31 | 2% |
| Omnia Srl | 31 | 2% |
| Exact Medical Manufacturing, Inc. | 21 | 1% |
Company = labeler of record on GUDID. 64 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 | 971 |
| FYA | Gown, Surgical | 957 |
| LYU | Accessory, Surgical Apparel | 101 |
| OEA | Non-Surgical Isolation Gown | 70 |
| KKX | Drape, surgical | 38 |
| FME | Gown, Examination | 12 |
Use these as the dimensions to specify in a tender line.
1,850 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical gown, single-use", from 64 companies. The largest labeler is Gri Medical & Electronic Technology Co., Ltd. with 24% of records.
FYA (GOWN, SURGICAL), FYA (Gown, Surgical), LYU (Accessory, Surgical Apparel), 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.