Disposable Vinyl Examination Gloves

Vinyl Patient Examination Glove

Shandong Zhushi Pharmaceutical Group Co., Ltd

The following data is part of a premarket notification filed by Shandong Zhushi Pharmaceutical Group Co., Ltd with the FDA for Disposable Vinyl Examination Gloves.

Pre-market Notification Details

Device IDK203439
510k NumberK203439
Device Name:Disposable Vinyl Examination Gloves
ClassificationVinyl Patient Examination Glove
Applicant Shandong Zhushi Pharmaceutical Group Co., Ltd No.6 Shande Road, Shan County Heze,  CN 274300
ContactJunhui Zhu
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. Room608,No.738,Shangcheng Rd.,Pudong Shanghai,  CN 200120
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-23
Decision Date2021-02-26

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