The following data is part of a premarket notification filed by Jiangsu Cureguard Glove Co., Ltd. with the FDA for Disposable Nitrile Examination Glove.
| Device ID | K222937 |
| 510k Number | K222937 |
| Device Name: | Disposable Nitrile Examination Glove |
| Classification | Polymer 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. 1801, No. 16 Lujiazui East Rd., Pudong Shanghai, CN 200120 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-26 |
| Decision Date | 2022-10-01 |