Convertors
Surgical Gown Non-Sterile Astound Fabric-Reinforced AAMI Level 3 Large Set-In Sleeve Non-Sterile
68manufacturers in China registered for this device type
184catalogue 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 |
| Premarket notification | Exempt |
| Record published | 2016-09-19 |
| Record revised | 2026-04-23 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 20, case of 18, case of 14, case of 16, case of 12, case of 24 |
| Distribution end date | 2028-02-21 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 9511 | In distribution | ||
| C9515N | 840 | In distribution | |
| 9041EL | In distribution | ||
| 9545ELA | In distribution | ||
| 9070NA | 600 | In distribution | |
| 9545 | In distribution | ||
| 9571NA | 540 | In distribution | |
| 39079 | In distribution | ||
| 9545ELNA | 20 | In distribution | |
| 39019 | In distribution | ||
| C9011 | In distribution | ||
| 99045N | 720 | In distribution | |
| 99015 | In distribution | ||
| K9575N | 16 | In distribution | |
| K89045N | 20 | In distribution | |
| 9515NB | 840 | In distribution | |
| 9010 | In distribution | ||
| 9541 | In distribution | ||
| 89095 | In distribution | ||
| 9545NC | 780 | In distribution | |
| 89045 | In distribution | ||
| 99045 | In distribution | ||
| 9011EL | In distribution | ||
| 9575 | In distribution | ||
| 39099N | 480 | In distribution | |
| 39075NB | 540 | In distribution | |
| 89015NB | 720 | In distribution | |
| 9515 | In distribution | ||
| 89085N | 20 | In distribution | |
| 99075N | 600 | In distribution | |
| 9011ELNA | 600 | In distribution | |
| 9041 | In distribution | ||
| 9011EL | In distribution | ||
| 9505 | In distribution | ||
| 32474 | In distribution | ||
| 32474 | In distribution | ||
| 32474 | In distribution | ||
| 9071EL | In distribution | ||
| 9585 | In distribution | ||
| 99075 | In distribution | ||
| C9041 | In distribution | ||
| C9545 | In distribution | ||
| 39079NB | 540 | In distribution | |
| 39049 | In distribution | ||
| C32474 | In distribution | ||
| 95995N | 22 | In distribution | |
| 90020N | 440 | In distribution | |
| 91070NB | 600 | In distribution | |
| 95998N | In distribution | ||
| 39045 | In distribution | ||
| 39045NA | 600 | In distribution | |
| 9575NB | 600 | In distribution | |
| 9575ELNA | 18 | In distribution | |
| 9571NA | 540 | In distribution | |
| K89075NA | 20 | In distribution | |
| 32474NA | 540 | In distribution | |
| 91070NB | 600 | In distribution | |
| C9545N | 720 | In distribution | |
| C9545 | In distribution | ||
| 39575 | In distribution | ||
| 9515 | In distribution | ||
| 89095N | 18 | In distribution | |
| 39075N | 480 | In distribution | |
| C9575 | In distribution | ||
| 89085 | In distribution | ||
| 9040 | In distribution | ||
| 39049NA | 600 | In distribution | |
| 89005 | In distribution | ||
| 89015 | In distribution | ||
| 9040 | In distribution | ||
| 39075 | In distribution | ||
| 89075 | In distribution | ||
| 9071 | In distribution | ||
| 39099 | In distribution | ||
| 9011ELNB | 840 | In distribution | |
| 9578 | In distribution | ||
| 9575 | In distribution | ||
| 9578NA | 680 | In distribution | |
| 39015 | In distribution | ||
| 9041ELNA | 600 | In distribution | |
| K9515N | 20 | In distribution | |
| 9011ELN | 480 | In distribution | |
| 39075NA | 432 | In distribution | |
| C9515 | In distribution | ||
| 39515 | In distribution | ||
| 9070 | In distribution | ||
| 9010 | In distribution | ||
| 89045NB | 720 | In distribution | |
| 39079N | 480 | In distribution | |
| 9518 | In distribution | ||
| K9545N | 18 | In distribution | |
| 99015N | 720 | In distribution | |
| 89005N | 26 | In distribution | |
| 39019N | 20 | In distribution | |
| 89015N | 520 | In distribution | |
| 95998 | In distribution | ||
| 9560N | 22 | In distribution | |
| 9041EL | In distribution | ||
| 9041 | In distribution | ||
| 9575EL | In distribution | ||
| C9041NA | 600 | In distribution | |
| 9571 | In distribution | ||
| K39015N | 24 | In distribution | |
| 9585N | 20 | In distribution | |
| 90680NA | 520 | In distribution | |
| 9571 | In distribution | ||
| 9548 | In distribution | ||
| 9511 | In distribution | ||
| 9541NA | 720 | In distribution | |
| 9541 | In distribution | ||
| 9010 | In distribution | ||
| 89075 | In distribution | ||
| 39099 | In distribution | ||
| 9041 | In distribution | ||
| 39045NB | 720 | In distribution | |
| K39049N | 22 | In distribution | |
| 89045NA | 600 | In distribution | |
| C9575N | 680 | In distribution | |
| 9560 | In distribution | ||
| 39079NA | 432 | In distribution | |
| C9515 | Withdrawn | ||
| 39545NA | 700 | Withdrawn | |
| 9071N | 480 | Withdrawn | |
| 89015 | Withdrawn | ||
| 9071EL | Withdrawn | ||
| 9571 | Withdrawn | ||
| 39545 | Withdrawn | ||
| 39049 | Withdrawn | ||
| ASG9545 | Withdrawn | ||
| 39049N | 480 | Withdrawn | |
| 89013 | Withdrawn | ||
| 89075N | 480 | Withdrawn | |
| 90970N | 400 | Withdrawn | |
| 324740N | 384 | Withdrawn | |
| 9071ELN | 480 | Withdrawn | |
| 9511NA | 640 | Withdrawn | |
| 890045N | 400 | Withdrawn | |
| 39575 | Withdrawn | ||
| 9505 | Withdrawn | ||
| 890015N | 400 | Withdrawn | |
| 9541 | Withdrawn | ||
| 390270NA | 600 | Withdrawn | |
| 39045 | Withdrawn | ||
| 9071EL | Withdrawn | ||
| 9545NC | 780 | Withdrawn | |
| 9575 | Withdrawn | ||
| 39045N | 520 | Withdrawn | |
| 9545ELA | Withdrawn | ||
| 39015N | 520 | Withdrawn | |
| 9070N | 440 | Withdrawn | |
| 89045N | 520 | Withdrawn | |
| 39075 | Withdrawn | ||
| 95995N | 22 | Withdrawn | |
| 39049 | Withdrawn | ||
| 95998 | Withdrawn | ||
| 9011 | Withdrawn | ||
| 9040 | Withdrawn | ||
| 9515 | Withdrawn | ||
| C9011 | Withdrawn | ||
| ASG9515 | Withdrawn | ||
| 89015 | Withdrawn | ||
| 90030N | 440 | Withdrawn | |
| 39015 | Withdrawn | ||
| C32474 | Withdrawn | ||
| 9505 | Withdrawn | ||
| 9011 | Withdrawn | ||
| 9518 | Withdrawn | ||
| C9545 | Withdrawn | ||
| 89045 | Withdrawn | ||
| 89045 | Withdrawn | ||
| 9548 | Withdrawn | ||
| 9515NB | 840 | Withdrawn | |
| 9578 | Withdrawn | ||
| 9560 | Withdrawn | ||
| 9518 | Withdrawn | ||
| 39515 | Withdrawn | ||
| C9515 | Withdrawn | ||
| C9041N | 520 | Withdrawn | |
| 89005 | Withdrawn | ||
| 9071 | Withdrawn | ||
| 9545 | Withdrawn | ||
| 95995 | Withdrawn | ||
| 9575NB | 600 | Withdrawn | |
| C9575 | 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 |
| 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 |
| Cardinal Health | Cardinal Health 200, LLC | 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 Naming This Product
8 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 | UDI-DI | 2021-11-02 | Class II | Process control | Potential for open packaging seals compromising the sterility of the surgical gowns | 224,312 units |
| Cardinal Health | UDI-DI | 2021-11-02 | Class II | Process control | Potential for open packaging seals compromising the sterility of the surgical gowns | 17,174 units |
| Cardinal Health | UDI-DI | 2021-11-02 | Class II | Process control | Potential for open packaging seals compromising the sterility of the surgical gowns | 146,939 units |
| Cardinal Health | UDI-DI | 2021-11-02 | Class II | Process control | Potential for open packaging seals compromising the sterility of the surgical gowns | 29,893 units |
| Cardinal Health | UDI-DI | 2021-11-02 | Class II | Process control | Potential for open packaging seals compromising the sterility of the surgical gowns | 364,481 units |
| Cardinal Health | UDI-DI | 2021-11-02 | Class II | Process control | Potential for open packaging seals compromising the sterility of the surgical gowns | 270,839 units |
| Cardinal Health | UDI-DI | 2021-11-02 | Class II | Process control | Potential for open packaging seals compromising the sterility of the surgical gowns | 9,990 units |
| Cardinal Health | UDI-DI | 2021-11-02 | Class II | Process control | Potential for open packaging seals compromising the sterility of the surgical gowns | 8,950 units |
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.