Copioumed
Copioumed’s Isolation Gown is intended to protect health care patients and health care personal from the transfer of microorganisms, body fluids and particulate material.Isolation Gown is a…
Copioumed’s Isolation Gown is intended to protect health care patients and health care personal from the transfer of microorganisms, body fluids and particulate material.Isolation Gown is a single use, disposable medical device provided non-sterile.
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 | Copioumed International, Inc., China |
|---|---|
| FDA product code | FYC |
| Device type | Gown, Isolation, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K230135 |
| Record published | 2022-09-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Carton of 10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| IGN3Y1032-1 | 10 | In distribution | |
| CTN3B102-1 | 10 | In distribution | |
| CTN3B101-1 | 10 | In distribution | |
| CTN3B202-1 | 10 | In distribution | |
| CTN3B104-1 | 10 | In distribution | |
| CTN3B303-1 | 10 | In distribution | |
| CTN3B201-1 | 10 | In distribution | |
| CTN3B203-1 | 10 | In distribution | |
| CTN3B103-1 | 10 | In distribution | |
| CTN3B301-1 | 10 | In distribution | |
| CTN3B302-1 | 10 | In distribution | |
| CTN3B204-1 | 10 | In distribution | |
| CTN3B304-1 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 14 |
| Novo Health Services, LLC | Novo Health Services, LLC | 12 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230135 | 2023-10-04 |
| K960999 | 1996-12-30 |
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.