The following data is part of a premarket notification filed by Yunnan Huazhiyuan Medical Technology Co., Ltd. with the FDA for Synthetic Vinyl Examination Gloves.
| Device ID | K212002 |
| 510k Number | K212002 |
| Device Name: | Synthetic Vinyl Examination Gloves |
| Classification | Vinyl 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.1801,No.161,East Lujiazui Rd.,Pudong Shanghai, CN 200120 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-28 |
| Decision Date | 2021-09-23 |