The following data is part of a premarket notification filed by Jiangsu Dongxin Medical Technology Co., Ltd with the FDA for Powder Free Nitrile Patient Examination Gloves, Blue Color.
Device ID | K181106 |
510k Number | K181106 |
Device Name: | Powder Free Nitrile Patient Examination Gloves, Blue Color |
Classification | Polymer Patient Examination Glove |
Applicant | JiangSu DongXin Medical Technology Co., Ltd LongJin Road, The Economic Development Zone Of SuCheng Suqian, CN 223800 |
Contact | Deng Yujie |
Correspondent | Chu Xiaoan Beijing Easylink Co., Ltd Rm. F302 Bldg., 41, Jing Cheng Ya Ju, Courtyard 6 of Southern Dou Ge Zhuang Beijing, CN 100021 |
Product Code | LZA |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-04-26 |
Decision Date | 2019-01-16 |
Summary: | summary |