The following data is part of a premarket notification filed by Zhongshan Saifute Labor Protective Articles Co., Ltd with the FDA for Surgical Face Mask.
|Device Name:||Surgical Face Mask|
|Applicant||Zhongshan Saifute Labor Protective Articles CO., LTD No.7, Xihuan 4th Road, Southern District Zhongshan, CN 528400|
Zhongshan Saifute Labor Protective Articles CO., LTD No.7, Xihuan 4th Road, Southern District Zhongshan, CN 528400
|CFR Regulation Number||878.4040 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|