The following data is part of a premarket notification filed by Wuhan Zonsen Medical Products Co.,ltd with the FDA for Nitrile Examination Gloves (model: Zmg1351).
| Device ID | K213688 |
| 510k Number | K213688 |
| Device Name: | Nitrile Examination Gloves (Model: ZMG1351) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Wuhan Zonsen Medical Products Co.,Ltd No 8 Jinchao Road, Zhucheng Street, Xinzhou District Wuhan, CN 431400 |
| Contact | Cynthia Ye |
| Correspondent | Doris Dong Shanghai CV Technology Co., Ltd. Room 903, No.19 Dongbao Road, Songjiang Area Shanghai, CN 201613 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-23 |
| Decision Date | 2022-02-18 |