CustoMed
GOWN SURGICAL POLY-REINFORCED SOFT A garment made of natural and/or synthetic materials intended to be worn over a scrub suit to cover the arms, trunk, and upper legs, during a surgical…
GOWN SURGICAL POLY-REINFORCED SOFT A garment made of natural and/or synthetic materials intended to be worn over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.
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 | Kenpax International Limited, Hong Kong |
|---|---|
| FDA product code | FYA |
| Device type | Gown, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Record published | 2020-07-16 |
| Record revised | 2021-04-07 (version 2) |
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, serial number |
| Packaging | Case of 30, case of 50, case of 20, case of 22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution |
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
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.