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 |
20194484320717 | K212578 | 000 |
20194484320700 | K212578 | 000 |
20194484320694 | K212578 | 000 |
20194484320687 | K212578 | 000 |
00686864061212 | K212578 | 000 |
00686864061205 | K212578 | 000 |
00686864061199 | K212578 | 000 |
00686864061182 | K212578 | 000 |
20194484320724 | K212578 | 000 |
20194484320533 | K212578 | 000 |
20194484320472 | K212578 | 000 |
20194484320465 | K212578 | 000 |
20194484320458 | K212578 | 000 |
20194484320441 | K212578 | 000 |
20194484320571 | K212578 | 000 |
20194484320564 | K212578 | 000 |
20194484320557 | K212578 | 000 |
20194484320540 | K212578 | 000 |
00686864061175 | K212578 | 000 |