The following data is part of a premarket notification filed by Jiangxi Sanhao Medical Instruments Co.,ltd with the FDA for Medical Nitrile Examination Gloves (model: Sh001).
| Device ID | K213600 |
| 510k Number | K213600 |
| Device Name: | Medical Nitrile Examination Gloves (Model: SH001) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Jiangxi SanHao Medical Instruments Co.,Ltd Chengxi Industrial Park, Jishui County, Ji'an, CN 331699 |
| Contact | Wangfenfang No Last Name Provided |
| Correspondent | Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road Huangpu District, Guangzhou, CN |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-15 |
| Decision Date | 2022-02-19 |