Disposable, Vinyl Examination Gloves, Yellow

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 Disposable, Vinyl Examination Gloves, Yellow.

Pre-market Notification Details

Device IDK220055
510k NumberK220055
Device Name:Disposable, Vinyl Examination Gloves, Yellow
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)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-06
Decision Date2022-08-25

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