A form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large particles (e.g., body fluids, airborne particulate materials) and small particles (e
| Company | Devices | Share |
|---|---|---|
| Ascend Eagle Incorporated | 62 | 16% |
| Crosstex International, Inc. | 51 | 13% |
| Mckesson Medical-Surgical Inc. | 22 | 6% |
| Icp, Inc. | 19 | 5% |
| Maytex Corporation | 17 | 4% |
| Safco Dental Supply Co. | 13 | 3% |
| 3M Company | 13 | 3% |
| Henry Schein, Inc. | 13 | 3% |
| Bound Tree Medical, Llc | 12 | 3% |
| Moldex-Metric, Inc. | 11 | 3% |
| O&M Halyard, Inc. | 11 | 3% |
| Makrite Hubei Industrial Co., Ltd. | 7 | 2% |
Company = labeler of record on GUDID. 61 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 |
|---|---|---|
| FXX | Mask, Surgical | 122 |
| FXX | Mask, surgical | 105 |
| MSH | Respirator, Surgical | 62 |
| LYU | Accessory, Surgical Apparel | 58 |
| MSH | Respirator,Surgical | 23 |
| MSH | Respirator, surgical | 21 |
Use these as the dimensions to specify in a tender line.
382 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical/medical respirator, non-antimicrobial, single-use", from 61 companies. The largest labeler is Ascend Eagle Incorporated with 16% of records.
FXX (Mask, Surgical), FXX (Mask, surgical), MSH (Respirator, Surgical), LYU (Accessory, Surgical Apparel)
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.