The following data is part of a premarket notification filed by Jiangsu Cureguard Glove Co., Ltd. with the FDA for Disposable Synthetic Vinyl Nitrile Examination Glove.
| Device ID | K211354 |
| 510k Number | K211354 |
| Device Name: | Disposable Synthetic Vinyl Nitrile Examination Glove |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Jiangsu Cureguard Glove Co., Ltd. No. 65 Shenzhen Road, The Economic Development Zone Suqian, CN 223800 |
| Contact | Guo Hua |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.608,No.738,Shangcheng Rd.,Pudong Shanghai, CN 200120 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-03 |
| Decision Date | 2021-08-08 |