The following data is part of a premarket notification filed by Guangdong Jiali Pharmaceutical Co.,ltd with the FDA for Medical Nitrile Examination Gloves (model: Jl001).
| Device ID | K213848 |
| 510k Number | K213848 |
| Device Name: | Medical Nitrile Examination Gloves (Model: JL001) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Guangdong Jiali Pharmaceutical Co.,Ltd Dawei, Niugutian Villagers Committee, Muzhou Town, Xinhui Jiangmen, CN 529143 |
| Contact | Jiali Chen |
| Correspondent | Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huang 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 | 2022-03-25 |