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 |