The following data is part of a premarket notification filed by Xingyu Medical Tech Co., Ltd. with the FDA for Nitrile Disposable Examination Gloves.
| Device ID | K212578 |
| 510k Number | K212578 |
| Device Name: | Nitrile Disposable Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Xingyu Medical Tech Co., Ltd. No. 2189 Yaoqian Road, Gaomi Economic Development Zone Weifang, CN |
| Contact | Cathrine Luan |
| Correspondent | Eva Li Shanghai Sungo Management Consulting Company Limited Room 1309, Dongfang Building, 1500# Century Ave Shanghai, CN 200122 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-16 |
| Decision Date | 2021-12-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06975016721727 | K212578 | 000 |
| 20194484320694 | K212578 | 000 |
| 20194484320700 | K212578 | 000 |
| 20194484320717 | K212578 | 000 |
| 20194484320724 | K212578 | 000 |
| 20194484320533 | K212578 | 000 |
| 20194484320540 | K212578 | 000 |
| 20194484320557 | K212578 | 000 |
| 20194484320564 | K212578 | 000 |
| 20194484320571 | K212578 | 000 |
| 20194484320441 | K212578 | 000 |
| 20194484320458 | K212578 | 000 |
| 20194484320465 | K212578 | 000 |
| 20194484320472 | K212578 | 000 |
| 20194484320687 | K212578 | 000 |