The following data is part of a premarket notification filed by Shandong Shangwei Medical Products Co.,ltd with the FDA for Powder Free Vinyl Patient Examination Gloves, Clear (non-colored).
Device ID | K210780 |
510k Number | K210780 |
Device Name: | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
Classification | Vinyl 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 | LYZ |
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 | 2021-05-14 |