The following data is part of a premarket notification filed by Siyang Threeguard Medical Supplies Co.,ltd. with the FDA for Disposable Nitrile Medical Examination Glove (tested For Use With Chemotherapy Drugs).
Device ID | K212834 |
510k Number | K212834 |
Device Name: | Disposable Nitrile Medical Examination Glove (Tested For Use With Chemotherapy Drugs) |
Classification | Polymer Patient Examination Glove |
Applicant | Siyang Threeguard Medical Supplies Co.,Ltd. East Of Nanhai Road And South Of Guilin Road, Economic Development Zone, Siyang County Suqian, CN 223799 |
Contact | Guo Hua |
Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161,East Lujiazui 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 | 2021-09-07 |
Decision Date | 2021-12-30 |