Primed
AAMI Level 3 Isolation Gown, Ties, Thumbloop with Elastic Cuff, Full Back, Universal, Yellow
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 | Primed Medical Products Inc., Canada |
|---|---|
| FDA product code | FYC |
| Device type | Gown, Isolation, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Record published | 2025-07-15 |
| Record revised | 2026-07-22 (version 3) |
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, manufacturing date |
| Storage | Special storage condition: Store in cool, dry, and well ventilated space out of direct sunlight. |
| Packaging | Case of 10 |
| Distribution end date | 2026-07-22 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PM4-58193 | 10 | In distribution | |
| PM4-57163XL | 10 | In distribution | |
| PM4-58493XL | 10 | In distribution | |
| PM4-57193 | 10 | In distribution | |
| PM4-57163 | 10 | In distribution | |
| PM4-58493 | 10 | In distribution | |
| PM4-57193XL | 10 | Withdrawn | |
| PM4-57493 | 10 | Withdrawn |
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 |
| Plus Medical Isolation Gown Level 3 | Foshan Nanhai Plus Medical Co Ltd | 8 |
| Halyard | O&M Halyard, 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 |
|---|---|
| K160361 | 2016-11-04 |
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.