The following data is part of a premarket notification filed by Dezhou Hengchang Medical Technology Co., Ltd with the FDA for Disposable, Vinyl Examination Gloves, Yellow.
|Device Name:||Disposable, Vinyl Examination Gloves, Yellow|
|Classification||Vinyl Patient Examination Glove|
|Applicant||Dezhou Hengchang Medical Technology Co., Ltd West Side Of South Tiandingfeng Road, Xingtong Sub-district Office, Linyi County, Dezhou City, CN 251500|
Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161 Lujiazui East Rd.,Pudong Shanghai, CN 200120
|CFR Regulation Number||880.6250 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|