Vinyl/Nitrile Blend Exam Glove

Vinyl Patient Examination Glove

Dezhou Hengchang Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Dezhou Hengchang Medical Technology Co., Ltd. with the FDA for Vinyl/nitrile Blend Exam Glove.

Pre-market Notification Details

Device IDK213634
510k NumberK213634
Device Name:Vinyl/Nitrile Blend Exam Glove
ClassificationVinyl 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
ContactJing Li
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161 Lujiazui East Rd.,Pudong Shanghai,  CN 200120
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-17
Decision Date2022-02-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.