Disposable Nitrile Examination Gloves

Polymer 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 Nitrile Examination Gloves.

Pre-market Notification Details

Device IDK203436
510k NumberK203436
Device Name:Disposable Nitrile Examination Gloves
ClassificationPolymer 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. Room 608, No. 738, Shangcheng Rd., Pudong Shanghai,  CN 200120
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-23
Decision Date2021-04-28

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