The following data is part of a premarket notification filed by Jiangsu Cureguard Glove Co., Ltd. with the FDA for Disposable Nitrile Medical Examination Glove (tested For Use With Chemotherapy).
Device ID | K211608 |
510k Number | K211608 |
Device Name: | Disposable Nitrile Medical Examination Glove (Tested For Use With Chemotherapy) |
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.161 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 | 2021-05-25 |
Decision Date | 2021-08-05 |