The following data is part of a premarket notification filed by Hengchang (dongying) Medical Technology Co.,ltd. with the FDA for Nitrile Exam Gloves, Powder Free, Blue.
|Device Name:||Nitrile Exam Gloves, Powder Free, Blue|
|Classification||Polymer Patient Examination Glove|
|Applicant||Hengchang (Dongying) Medical Technology Co.,Ltd. Room 101, Building 2, No.26 Xinghe Road, Niuzhuang Town, Dongying District Dongying, CN|
Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161, East Lujiazui Rd., Pudong Shanghai, CN 200120
|CFR Regulation Number||880.6250 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|