Critical Cover
Shoe Cover, GenPro, Anti-Skid Adhesive on Sole, Serged Seams, Blue, Universal.
32manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (11), Hubei (8), Shanghai (3). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Holymed Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Wuhan Huaxin Nonwoven Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 13 |
| Hubei Weikang Protective Products Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 12 |
| Aimmax Medical Products Co., Ltd. | Shiyan | Hubei | Contract manufacturer | 10 |
| Jiangsu Hanfang Textile Technology Co., Ltd. | Xuzhou | Jiangsu | Contract manufacturer | 8 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Planet(Shanghai) International Co., Ltd. | Shanghai | Shanghai | Exporter | 93 |
| Planet (Anhui) International Co., Ltd. | Chuzhou | Anhui | Exporter | 80 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
Showing 12 of 32. All 32 manufacturers in China registered for Shoe And Shoe Cover, Conductive
Record
| Listed by | Alpha Pro Tech, Inc. |
|---|---|
| FDA product code | BWP |
| Device type | Shoe And Shoe Cover, Conductive |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4040 |
| Premarket notification | Exempt |
| Record published | 2018-07-16 |
| Record revised | 2025-06-09 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
| Packaging | Case, case of 3 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SH-71222-B | 100 | In distribution | |
| SH-12524-B | 300 | In distribution | |
| SH-12522-B | 300 | In distribution | |
| SH-12523-B | 300 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| PremierPro | Prestige Ameritech | 10 |
| GCB Medical Supply | GCB Medical LLC | 8 |
| Protexer | ICP, Inc. | 7 |
| AMG | Arrow Medsource Group Limited | 3 |
| Top Quality Manufacturing | TOP Quality Manufacturing, Inc. | 1 |
| Medline Industries, Inc. | Medline Industries, Inc. | 1 |
| Disposable Boot Cover | TNG Investment AND Trading Joint Stock Company | 1 |
| GCB Medical Supply Novaplus | GCB Medical LLC | 1 |
| Neulynx Shoe Covers | Medgluv Inc. | 1 |
| ProCure | Twin Med, LLC | 1 |
| Operating-Room Shoe Cover | Hangzhou A-Tek Medical & Textiles Co., Ltd. | 1 |
| Copioumed | Copioumed International, Inc. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.