Dukal
Level 2 Poly Coated Isolation Gown, Universal, Yellow
318manufacturers in China registered for this device type
27catalogue numbers in this listing
Who Else Makes It
Concentrated in Hubei (71), Jiangsu (59), Zhejiang (42). 83 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Anqing Kangmingna Packaging Co., Ltd. | Anqing | Anhui | Contract manufacturer | 39 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Taizhou Xinkang Medical Materials Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 35 |
| Jiangsu Guangda Medical Material Group Co., Ltd. | Haian | Jiangsu | Contract manufacturer | 32 |
| Evereast Medical Products Group Co., Ltd. | Changyuan | Henan | Contract manufacturer | 30 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 26 |
| Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. | Jingmen | Hubei | Contract manufacturer | 23 |
Showing 12 of 318. All 318 manufacturers in China registered for Non-Surgical Gown
Record
| Listed by | Dukal LLC, United States |
|---|---|
| FDA product code | OEA |
| Device type | Non-Surgical Gown |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-06 |
| Record revised | 2024-11-14 (version 2) |
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 |
| Packaging | Case of 5, case of 10, case of 3 |
| Distribution end date | 2024-11-13 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| G1005 | 10 | In distribution | |
| 308 | 10 | In distribution | |
| G1006 | 10 | In distribution | |
| 303BL | 10 | In distribution | |
| 309XL | 10 | In distribution | |
| 301XL | 10 | In distribution | |
| 307R | 15 | In distribution | |
| 301 | 10 | In distribution | |
| 301BL and 301BL-10 | 10 | In distribution | |
| 301SP | 10 | In distribution | |
| G1007 | 10 | In distribution | |
| 315 | 10 | In distribution | |
| G1008 | 10 | In distribution | |
| 301XXL | 10 | In distribution | |
| 303 | 10 | In distribution | |
| 307XL | 15 | In distribution | |
| 308XL | 10 | In distribution | |
| 309 | 10 | In distribution | |
| 309T-GSS | 10 | Withdrawn | |
| 303L2-Y | 10 | Withdrawn | |
| 315-GSS | 10 | Withdrawn | |
| 309XXL-GSS | 10 | Withdrawn | |
| 309TXL-GSS | 10 | Withdrawn | |
| 309XL-GSS | 10 | Withdrawn | |
| 309-GSS | 10 | Withdrawn | |
| 303L2-B | 10 | Withdrawn | |
| 303L2XL-Y | 10 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 230 |
| Henry Schein | Henry Schein, Inc. | 144 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 118 |
| Medline | Medline Industries, Inc. | 99 |
| Precaution/Isolation Gown | Standard Textile Co., Inc. | 83 |
| PremierPro | Prestige Ameritech | 74 |
| Alleset | GRI Medical & Electronic Technology Co., Ltd. | 71 |
| Medicom Safewear | AMD Medicom Inc. | 70 |
| Maytex | Maytex Corp. | 67 |
| Precept® | Precept Medical Products, Inc. | 61 |
| 3D Dental-Essentials | 3D Dental Designs AND Development, LLC | 56 |
| Halyard | O&M Halyard, Inc. | 53 |
Showing 12 of 230. All products under Non-Surgical Gown
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.