Cardinal Health
Isolation Gown; AAMI Level 3; Over-the-head; Elastic Wrist & Thumbhooks; Yellow; Universal
21manufacturers in China registered for this device type
14catalogue numbers in this listing
2recalls on this code
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 | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | FYC |
| Device type | Gown, Isolation, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2022-02-14 |
| Record revised | 2026-06-26 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Case of 10 |
| Distribution end date | 2027-10-21 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| AT6588-XL | 10 | In distribution | |
| AT6688-2XL | 10 | In distribution | |
| AT6100 | 10 | In distribution | |
| AT6688-XL | 10 | In distribution | |
| AT6200-XL | 10 | In distribution | |
| AT6100-XL | 10 | In distribution | |
| AT6688-BD | 10 | In distribution | |
| AT6200 | 10 | In distribution | |
| AT6588-2XL | 10 | In distribution | |
| AT6588-BD | 10 | In distribution | |
| AT6100-XL | 10 | Withdrawn | |
| AT6100 | 10 | Withdrawn | |
| AT6200-XL | 10 | Withdrawn | |
| AT6200 | 10 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Cardinal Health 200, LLC | UDI-DI | 2024-11-01 | Class II | Nonconforming Material/Component | Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection requireme | 940,203 total units |
| Cardinal Health 200, LLC | UDI-DI | 2024-11-01 | Class II | Nonconforming Material/Component | Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection requireme | 940,203 total units |
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.