A loose fabric covering intended to be placed over a shoe to create a physical barrier to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the shoe and the environment, or a patient and staff. It
| Company | Devices | Share |
|---|---|---|
| Alpha Pro Tech, Inc. | 68 | 19% |
| Tronex International, Inc. | 27 | 7% |
| Medline Industries, Inc. | 24 | 7% |
| Cardinal Health 200, Llc | 23 | 6% |
| Batrik Medical Manufacturing Inc | 15 | 4% |
| O&M Halyard, Inc. | 14 | 4% |
| Asp Global, Llc | 12 | 3% |
| Precept Medical Products, Inc. | 11 | 3% |
| Prestige Ameritech, Ltd. | 10 | 3% |
| Jeg & Sons Inc. | 10 | 3% |
| Resource Optimization & Innovation, L.L.C. | 10 | 3% |
| Gcb Medical Llc | 9 | 2% |
Company = labeler of record on GUDID. 55 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 |
|---|---|---|
| FXP | Cover, Shoe, Operating-Room | 258 |
| FXP | COVER, SHOE, OPERATING-ROOM | 99 |
| BWP | Shoe And Shoe Cover, Conductive | 36 |
| LYU | ACCESSORY, SURGICAL APPAREL | 4 |
| OEA | Non-Surgical Isolation Gown | 3 |
| PXG | Spill Kit | 2 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
361 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Shoe cover", from 55 companies. The largest labeler is Alpha Pro Tech, Inc. with 19% of records.
FXP (Cover, Shoe, Operating-Room), FXP (COVER, SHOE, OPERATING-ROOM), BWP (Shoe And Shoe Cover, Conductive), 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.