Nitrile Exam Gloves, Powder Free, Blue

Polymer Patient Examination Glove

Hengchang (Dongying) Medical Technology Co.,Ltd.

The following data is part of a premarket notification filed by Hengchang (dongying) Medical Technology Co.,ltd. with the FDA for Nitrile Exam Gloves, Powder Free, Blue.

Pre-market Notification Details

Device IDK211699
510k NumberK211699
Device Name:Nitrile Exam Gloves, Powder Free, Blue
ClassificationPolymer Patient Examination Glove
Applicant Hengchang (Dongying) Medical Technology Co.,Ltd. Room 101, Building 2, No.26 Xinghe Road, Niuzhuang Town, Dongying District Dongying,  CN
ContactLi Jing
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161, East Lujiazui Rd., Pudong Shanghai,  CN 200120
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-03
Decision Date2021-08-20

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