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4 catalogue numbers from 3011-BT, listed by Mazza Healthcare LLC, United States, under Cover, Shoe, Operating-Room. 176 manufacturers in China are registered for this product code.
176manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Hubei (61), Jiangsu (27), Zhejiang (22). 40 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Jiangsu Guangda Medical Material Group Co., Ltd. | Haian | Jiangsu | Contract manufacturer | 32 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
| Planet (Anhui) Medical Products Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 30 |
| Dongguan NAN YOU Sporting Goods Enterprise Ltd | Dongguan | Guangdong | Contract manufacturer | 23 |
| Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. | Jingmen | Hubei | Contract manufacturer | 23 |
| Hefei Xingcheng Sanitary Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 21 |
| Goodwood Medical Care Ltd | Dalian | Liaoning | Contract manufacturer | 19 |
| Changzhou Holymed Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Xiantao Daoqi Plastic Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 16 |
Showing 12 of 176. All 176 manufacturers in China registered for Cover, Shoe, Operating-Room
Record
| Listed by | Mazza Healthcare LLC, United States |
|---|---|
| FDA product code | FXP |
| Device type | Cover, Shoe, Operating-Room |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Complaint-file establishment |
| Premarket notification | Exempt |
| Record published | 2021-01-31 |
| Record revised | 2025-11-27 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Packaging | Case of 3 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 3011-BT | 50 | In distribution | |
| 3011 | 100 | In distribution | |
| 3012-BT | 50 | In distribution | |
| 3012 | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Critical Cover | Alpha Pro Tech, Inc. | 64 |
| Cardinal Health | Cardinal Health 200, LLC | 38 |
| Tronex International, Inc. | Tronex International, Inc. | 27 |
| Hygitech | Hygitech | 22 |
| Precept® | Precept Medical Products, Inc. | 18 |
| ASP Medical | ASP Global, LLC | 15 |
| Batrik ShoozCovers™ | Batrik Medical Manufacturing Inc. | 15 |
| McKesson | Mckesson Medical-Surgical Inc. | 13 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 12 |
| Medline | Medline Industries, Inc. | 11 |
| Halyard | O&M Halyard, Inc. | 10 |
| WeCare | Jeg & Sons Inc. | 10 |
Showing 12 of 66. All products under Cover, Shoe, Operating-Room
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.