DeRoyal
SPEYES™ S Eye Shield LensesThread Through
439manufacturers in China registered for this device type
35catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (94), Jiangsu (82), Guangdong (69). 76 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Planet (Anhui) Medical Products Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 30 |
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 26 |
| Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. | Jingmen | Hubei | Contract manufacturer | 23 |
| Yiwu Haoding Medical Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 23 |
| Anji Hengfeng Sanitary Material Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 20 |
| Hochuen Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
| Goodwood Medical Care Ltd | Dalian | Liaoning | Contract manufacturer | 19 |
| Wellpower Sporting Goods Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 18 |
Showing 12 of 439. All 439 manufacturers in China registered for Accessory, Surgical Apparel
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | LYU |
| Device type | Accessory, Surgical Apparel |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K941932 |
| Record published | 2023-02-02 |
| Record revised | 2024-12-02 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 50, case of 100, box of 25, case of 25, case of 120 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 23-800 | In distribution | |
| 23-906 | In distribution | |
| 31-127 | In distribution | |
| 23-806 | In distribution | |
| 23-705 | In distribution | |
| 23-007 | In distribution | |
| 23-003 | In distribution | |
| 23-505 | In distribution | |
| 23-805 | In distribution | |
| 23-500 | In distribution | |
| 23-100 | In distribution | |
| 23-900 | In distribution | |
| 23-701 | In distribution | |
| 23-34FS | In distribution | |
| 23-501 | In distribution | |
| 32-2086 | In distribution | |
| 23-201 | In distribution | |
| 23-004 | In distribution | |
| 23-502 | In distribution | |
| 23-410 | In distribution | |
| 32-988 | In distribution | |
| 23-801 | In distribution | |
| 23-005 | In distribution | |
| 23-002 | In distribution | |
| 23-905 | In distribution | |
| 23-901 | In distribution | |
| 32-2075 | In distribution | |
| 23-FRAME | In distribution | |
| 23-501B | In distribution | |
| 23-502B | In distribution | |
| 23-001 | In distribution | |
| 23-400 | In distribution | |
| 23-506 | In distribution | |
| 23-702 | In distribution | |
| 23-006 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Critical Cover | Alpha Pro Tech, Inc. | 177 |
| Cardinal Health | Cardinal Health 200, LLC | 167 |
| Halyard | O&M Halyard, Inc. | 117 |
| Tronex International, Inc. | Tronex International, Inc. | 108 |
| ASP Medical | ASP Global, LLC | 103 |
| Unipack | Unipack LLC | 90 |
| A Plus | A Plus International, Inc | 77 |
| Maxi-Gard | Henry Schein, Inc. | 76 |
| Resilient Medical Solutions | Resilient Medical Solutions, LLC | 61 |
| Dukal | Dukal LLC | 58 |
| MediChoice | Owens & Minor Distribution, Inc. | 55 |
| VR | Polyconversions, Inc. | 50 |
Showing 12 of 197. All products under Accessory, Surgical Apparel
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.