Blue Nitrile Exam Glove, Powder Free

Polymer Patient Examination Glove

Real Star Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Real Star Medical Technology Co., Ltd. with the FDA for Blue Nitrile Exam Glove, Powder Free.

Pre-market Notification Details

Device IDK210057
510k NumberK210057
Device Name:Blue Nitrile Exam Glove, Powder Free
ClassificationPolymer Patient Examination Glove
Applicant Real Star Medical Technology Co., Ltd. Youdi Industry Park In Dongying District, Dongying,  CN 257100
ContactNie Jian
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. RM.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 Received2021-01-11
Decision Date2021-03-31

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