Vinyl Examination Gloves(Yellow)

Vinyl Patient Examination Glove

Lutai Medical Technology Co.,LTD.

The following data is part of a premarket notification filed by Lutai Medical Technology Co.,ltd. with the FDA for Vinyl Examination Gloves(yellow).

Pre-market Notification Details

Device IDK203666
510k NumberK203666
Device Name:Vinyl Examination Gloves(Yellow)
ClassificationVinyl Patient Examination Glove
Applicant Lutai Medical Technology Co.,LTD. Tiandingfeng Road Dezhou,  CN 251500
ContactXiaomeng Xiaomeng Li
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 Received2020-12-16
Decision Date2021-03-12

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