Disposable Boot Cover
Non-woven fabric Disposable, lightweight, comfortable to wear, shoe protection
32manufacturers in China registered for this device type
1catalogue number
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 | TNG Investment AND Trading Joint Stock Company |
|---|---|
| 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 | 2020-08-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MDC-PS13 | 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 |
| AMG | Arrow Medsource Group Limited | 3 |
| Top Quality Manufacturing | TOP Quality Manufacturing, Inc. | 1 |
| Medline Industries, Inc. | Medline Industries, Inc. | 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.