AMG
Shoe Covers, Universal
32manufacturers in China registered for this device type
3catalogue 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 | Arrow Medsource Group Limited, China |
|---|---|
| FDA product code | BWP |
| Device type | Shoe And Shoe Cover, Conductive |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-06-22 |
| Record revised | 2021-04-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Packaging | Case of 10, case of 3 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SCS001XL | 100 | In distribution | |
| SCS001U | 100 | In distribution | |
| BC0001 | 50 | 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 |
| Critical Cover | Alpha Pro Tech, Inc. | 4 |
| 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.