The following data is part of a premarket notification filed by Guangdong Xingcan Brothers Medical Technology Co.,ltd with the FDA for Disposable Medical Nitrile Gloves.
| Device ID | K213851 |
| 510k Number | K213851 |
| Device Name: | Disposable Medical Nitrile Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Guangdong Xingcan Brothers Medical Technology Co.,Ltd Room B10, 4th Floor, No. 137 (plant A1), Pacific Industrial Zone, Xintang Town, Zengcheng District Guangzhou, CN |
| Contact | Suhai Yin |
| 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 | 2021-12-10 |
| Decision Date | 2022-03-09 |