The following data is part of a premarket notification filed by Yunnan Huazhiyuan Medical Technology Co., Ltd. with the FDA for Nitrile Patient Examination Glove.
| Device ID | K210686 |
| 510k Number | K210686 |
| Device Name: | Nitrile Patient Examination Glove |
| Classification | Polymer Patient Examination Glove |
| Applicant | Yunnan Huazhiyuan Medical Technology Co., Ltd. Yangjie Industrial Park, Jianshui County Honghe Hani And Yi Autonomous Prefecture, CN 654300 |
| Contact | Yun Gao |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.608, No. 738, Shangcheng 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 | 2021-03-08 |
| Decision Date | 2021-07-21 |