Cardinal Health
Surgical Gown Non-Sterile Poly-Reinforced AAMI Level 4 2X-Large X-Long
68manufacturers in China registered for this device type
35catalogue numbers in this listing
3510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (16), Hubei (13), Anhui (10). 28 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Henan Yadu Industrial Co., Ltd. | Changyuan | Henan | Contract manufacturer | 35 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Exact Medical Manufacturing, Inc. | Changzhou | Jiangsu | Contract manufacturer | 17 |
| Kingstar Medical (Xianning) Co., Ltd. | Xianning | Hubei | Contract manufacturer | 17 |
| Changzhou Holymed Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Weihai Dishang Medical Technology Co., Ltd. | Weihai | Shandong | Contract manufacturer | 16 |
| Lianyungang Bronson Non-woven Products Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 16 |
| Heyuan Hong DE Medical Products Co., Ltd. | Heyuan | Guangdong | Contract manufacturer | 13 |
Showing 12 of 68. All 68 manufacturers in China registered for Gown, Surgical
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | FYA |
| Device type | Gown, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-02 |
| Record revised | 2022-09-28 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 10, case of 50, case of 5 |
| Distribution end date | 2028-10-23 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 9578NB | 720 | In distribution | |
| 9010NB | 720 | In distribution | |
| 9040NB | 660 | In distribution | |
| 90380NC | 780 | In distribution | |
| 9200U | 10 | In distribution | |
| 90680NB | 600 | In distribution | |
| 9011NB | 720 | In distribution | |
| 90030NA | 600 | In distribution | |
| ASG9541EL | In distribution | ||
| 90020NA | 600 | In distribution | |
| 90280NC | 840 | In distribution | |
| 9071ELNA | 600 | In distribution | |
| ASG9511 | In distribution | ||
| 9511NB | 660 | In distribution | |
| 9200XL | 10 | In distribution | |
| 90780NB | 615 | In distribution | |
| SBAHBVPSCA | In distribution | ||
| SID25GBHMC | In distribution | ||
| 9200M | 10 | In distribution | |
| 9548NC | 900 | In distribution | |
| 39575NA | 520 | In distribution | |
| 9518NC | 840 | In distribution | |
| 9041NA | 600 | In distribution | |
| SOP11OHLVA | In distribution | ||
| 90370NB | 660 | In distribution | |
| 9071NA | 600 | In distribution | |
| ASG9541 | In distribution | ||
| 9200XXL | 10 | In distribution | |
| 90970NA | 600 | In distribution | |
| 90270NB | 672 | In distribution | |
| 324740NA | 480 | In distribution | |
| 90370NB | 660 | Withdrawn | |
| 90270NB | 672 | Withdrawn | |
| 39515NB | 756 | Withdrawn | |
| 390370NB | 600 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 453 |
| Halyard | O&M Halyard, Inc. | 248 |
| Novo Health Services, LLC | Novo Health Services, LLC | 222 |
| Alleset | GRI Medical & Electronic Technology Co., Ltd. | 214 |
| Convertors | Cardinal Health 200, LLC | 184 |
| Lac-Mac | LAC-MAC Limited | 157 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 126 |
| Exact Medical Manufacturing, Inc. | Exact Medical Manufacturing, Inc. | 107 |
| ComPel Surgical Gown | Standard Textile Co., Inc. | 67 |
| Halyard | GRI Medical & Electronic Technology Co., Ltd. | 55 |
| ComPel MLR Surgical Gown | Standard Textile Co., Inc. | 38 |
| Medline Industries, Inc. | Medline Industries, Inc. | 35 |
Showing 12 of 172. All products under Gown, Surgical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253243 | 2026-04-28 |
| K150151 | 2015-05-21 |
| K061308 | 2006-06-05 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-11-12 | Class II | Under Investigation by firm | Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years. | 251,165 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.