Disposable Synthetic Examination Gloves

Vinyl Patient Examination Glove

Shandong Shengshixincheng Medical Science & Technology Co.,

The following data is part of a premarket notification filed by Shandong Shengshixincheng Medical Science & Technology Co., with the FDA for Disposable Synthetic Examination Gloves.

Pre-market Notification Details

Device IDK210520
510k NumberK210520
Device Name:Disposable Synthetic Examination Gloves
ClassificationVinyl Patient Examination Glove
Applicant Shandong Shengshixincheng Medical Science & Technology Co., No.28 Aluminum Deep Processing Industrial Park, Changshan Town,Zouping Binzhou,  CN 256200
ContactPing Wang
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 Received2021-02-23
Decision Date2021-05-26

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