Disposable Vinyl Glove

Vinyl Patient Examination Glove

Best Care Trading Co., LTD

The following data is part of a premarket notification filed by Best Care Trading Co., Ltd with the FDA for Disposable Vinyl Glove.

Pre-market Notification Details

Device IDK202008
510k NumberK202008
Device Name:Disposable Vinyl Glove
ClassificationVinyl Patient Examination Glove
Applicant Best Care Trading Co., LTD Yuying Village, Fangzhen, Zhangdian District Zibo,  CN 255000
ContactChongfeng Zhao
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. RM. 608, No. 738, Shangcheng Rd., Pudong Shanghai,  CN 200120
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-21
Decision Date2020-09-10

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