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 and small particles during medical, surgical, dental, and isolation procedures; it i
| Company | Devices | Share |
|---|---|---|
| Plasdent Corporation | 19 | 37% |
| Nexera Medical, Llc | 12 | 24% |
| Medline Industries, Inc. | 8 | 16% |
| Bound Tree Medical, Llc | 5 | 10% |
| Unico Global Inc | 5 | 10% |
| Nbc Meshtec Inc. | 1 | 2% |
| Meijer, Inc. | 1 | 2% |
Company = labeler of record on GUDID. 7 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 | 23 |
| ONT | N95 Respirator With Antimicrobial/Antiviral Agent | 12 |
| OUK | Surgical Mask With Antimicrobial/Antiviral Agent | 7 |
| LYU | ACCESSORY, SURGICAL APPAREL | 5 |
| NZJ | Respirator, n95, for use by the general public in public hea | 5 |
| FXX | Mask, surgical | 5 |
Use these as the dimensions to specify in a tender line.
51 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical/medical respirator, antimicrobial", from 7 companies. The largest labeler is Plasdent Corporation with 37% of records.
FXX (Mask, Surgical), ONT (N95 Respirator With Antimicrobial/Antiviral Agent), OUK (Surgical Mask With Antimicrobial/Antiviral Agent), 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.