A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a member of the general public to permit normal breathing while protecting the wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate ma
| Company | Devices | Share |
|---|---|---|
| Medline Industries, Inc. | 39 | 35% |
| Jmu Dental, Inc | 14 | 12% |
| Trinity Sterile, Inc. | 8 | 7% |
| Guangzhou Zhengkang Medical Equipment Co., Ltd. | 7 | 6% |
| Zhejiang Lanhine Medical Products Ltd. | 6 | 5% |
| Dynarex Corporation | 6 | 5% |
| Walgreen Co. | 4 | 4% |
| Jiaxing Zhengqun Medical Devices Co.,Ltd | 3 | 3% |
| O&M Halyard, Inc. | 3 | 3% |
| Aok Tooling Limited | 3 | 3% |
| Song Hong Garment Joint Stock Co. | 2 | 2% |
| Mocacare Corp. | 2 | 2% |
Company = labeler of record on GUDID. 27 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 | 39 |
| FXX | Mask, surgical | 36 |
| LYU | Accessory, Surgical Apparel | 18 |
| QKR | Face Mask Within the Scope of the Face Mask and Barrier Face | 8 |
| QKR | Face Mask Per Enforcement Policy For Face Masks And Respirat | 4 |
| QKR | Face Mask (Except N95 Respirator) For General Public/Healthc | 3 |
Use these as the dimensions to specify in a tender line.
113 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Public face mask, single-use", from 27 companies. The largest labeler is Medline Industries, Inc. with 35% of records.
FXX (Mask, Surgical), FXX (Mask, surgical), LYU (Accessory, Surgical Apparel), QKR (Face Mask Within the Scope of the Face Mask and Barrier Face)
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.