A garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carri
| Company | Devices | Share |
|---|---|---|
| O&M Halyard, Inc. | 134 | 7% |
| Dukal Llc | 120 | 7% |
| Cardinal Health 200, Llc | 118 | 7% |
| Medline Industries, Inc. | 111 | 6% |
| Prestige Ameritech, Ltd. | 95 | 5% |
| Gri Medical & Electronic Technology Co., Ltd. | 89 | 5% |
| 3D Dental Designs And Development, Llc | 68 | 4% |
| Maytex Corporation | 67 | 4% |
| Precept Medical Products, Inc. | 61 | 3% |
| Amd Medicom Inc | 55 | 3% |
| Young Mydent, Llc | 54 | 3% |
| Jmu Dental, Inc | 51 | 3% |
Company = labeler of record on GUDID. 111 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 |
|---|---|---|
| OEA | Non-Surgical Isolation Gown | 618 |
| OEA | Non-surgical isolation gown | 441 |
| LYU | ACCESSORY, SURGICAL APPAREL | 236 |
| OEA | Non-Surgical Gown | 202 |
| FME | Gown, Examination | 116 |
| LYU | Accessory, Surgical Apparel | 107 |
Use these as the dimensions to specify in a tender line.
1,805 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Isolation gown, single-use", from 111 companies. The largest labeler is O&M Halyard, Inc. with 7% of records.
OEA (Non-Surgical Isolation Gown), OEA (Non-surgical isolation gown), LYU (ACCESSORY, SURGICAL APPAREL), OEA (Non-Surgical 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.