Novo Health Services, LLC
REX Onsite LP Decon GWN XLG NS
21manufacturers in China registered for this device type
12catalogue numbers in this listing
Who Else Makes It
Concentrated in Hubei (7), Jiangsu (3), Zhejiang (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Lianyungang Bronson Non-woven Products Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 16 |
| Lianyungang Anson Non-woven Product Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 13 |
| Copious Intl., Inc. | Heyuan, Guangdong Province | Contract manufacturer | 11 | |
| Primed Liyang Medical Products Manufacturing Co., Ltd. | Liyang | Jiangsu | Contract manufacturer | 11 |
| Gushi priMED Medical Products Manufacturing Co., Ltd. | Gushi County | Henan | Contract manufacturer | 9 |
| priMED Jiujiang Medical Products Manufacturing Co., Ltd. | Jiujiang | Jiangxi | Contract manufacturer | 7 |
| Nanning Tecbod Biological Technology Co., Ltd. | Nanning | Guangxi | Contract manufacturer | 51 |
| Zhejiang Medicines & Health Products I/ E Co., Ltd. | Hangzhou | Zhejiang | Exporter | 41 |
| Fesun Shanghai Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Wuhan Zonsen Medical Products Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 24 |
| Hangzhou Jincheng Medical Supplies Manufacture Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 15 |
| Copioumed International, Inc. | Taipei | Taiwan | Specification developer | 14 |
Showing 12 of 21. All 21 manufacturers in China registered for Gown, Isolation, Surgical
Record
| Listed by | Novo Health Services, LLC |
|---|---|
| FDA product code | FYC |
| Device type | Gown, Isolation, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| 510(k) | K920404 |
| Record published | 2018-10-05 |
| Record revised | 2020-07-31 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Weight 9 to 16.2 lb; width 16 to 19 in; height 5.5 to 6.5 in |
| Distribution end date | 2023-06-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 123878 | Withdrawn | |
| 8515 | Withdrawn | |
| 699200 | Withdrawn | |
| 8516 | Withdrawn | |
| 8517 | Withdrawn | |
| 123879 | Weight 16.2 lb | Withdrawn |
| 8508 | Withdrawn | |
| 699300 | Withdrawn | |
| 8509 | Withdrawn | |
| 123341 | Weight 9.0 lb | Withdrawn |
| 8507 | Withdrawn | |
| 699100 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 14 |
| Copioumed | Copioumed International, Inc. | 13 |
| MediChoice | Owens & Minor Distribution, Inc. | 8 |
| Plus Medical Isolation Gown Level 3 | Foshan Nanhai Plus Medical Co Ltd | 8 |
| Halyard | O&M Halyard, Inc. | 8 |
| Primed | Primed Medical Products Inc. | 8 |
| Alleset | GRI Medical & Electronic Technology Co., Ltd. | 7 |
| Calico | Calico Medical Group LLC | 7 |
| Protexer | ICP, Inc. | 6 |
| Essentials | Henry Schein, Inc. | 6 |
| Henry Schein | Henry Schein, Inc. | 6 |
| Vivit Supply | Vivit Supply LLC | 6 |
Showing 12 of 32. All products under Gown, Isolation, Surgical
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.