Plus Medical Isolation Gown Level 3
8 catalogue numbers from PM4407FG, listed by Foshan Nanhai Plus Medical Co Ltd, China, under Gown, Isolation, Surgical. 21 manufacturers in China are registered for this product code.
21manufacturers in China registered for this device type
8catalogue numbers in this listing
1510(k) clearance
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 | Foshan Nanhai Plus Medical Co Ltd, China |
|---|---|
| FDA product code | FYC |
| Device type | Gown, Isolation, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Contract manufacturer, Private-label distributor, Manufacturer, Exporter |
| 510(k) | K212698 |
| Record published | 2022-03-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PM4407FG | In distribution | |
| PM4403FG | In distribution | |
| PM4401FG | In distribution | |
| PM4406FG | In distribution | |
| PM4405FG | In distribution | |
| PM4402FG | In distribution | |
| PM4404FG | In distribution | |
| PM4408FG | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 14 |
| Copioumed | Copioumed International, Inc. | 13 |
| Novo Health Services, LLC | Novo Health Services, LLC | 12 |
| MediChoice | Owens & Minor Distribution, Inc. | 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 |
|---|---|
| K212698 | 2022-03-02 |
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.