The following data is part of a premarket notification filed by Shandong Shangwei Medical Products Co.,ltd with the FDA for Powder Free Nitrile Patient Examination Gloves, Blue Color.
| Device ID | K210779 |
| 510k Number | K210779 |
| Device Name: | Powder Free Nitrile Patient Examination Gloves, Blue Color |
| Classification | Polymer Patient Examination Glove |
| Applicant | Shandong Shangwei Medical Products Co.,Ltd North Road, Fumin Avenue, Qinghe Street, Caoxian County Heze, CN 274400 |
| Contact | Li Hua |
| Correspondent | Chu Xiaoan Beijing Easy-Link Company Rm. F302 Bldg., 41, Jing Cheng Ya Ju, Courtyard 6 Of Southern Dou Ge Zhuang, Chaoyung District Beijing, CN 100121 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-15 |
| Decision Date | 2021-11-10 |