The following data is part of a premarket notification filed by Jiangsu Cherish Medical Technology Co., Ltd with the FDA for Disposable Medical Nitrile Examination Gloves (non-sterile).
| Device ID | K211075 |
| 510k Number | K211075 |
| Device Name: | Disposable Medical Nitrile Examination Gloves (Non-Sterile) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Jiangsu Cherish Medical Technology Co., Ltd No. 55 Maqianan Chaoyang Road, Jiaoxi Centralized Industrial Zone Changzhou, CN 213000 |
| Contact | April Yao |
| Correspondent | Johnson Liu Cnmed Consultant 31 Archer St Upper Mt Gravatt, AU 4122 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-12 |
| Decision Date | 2021-08-05 |