Nitrile Glove Powder Free Blue

Polymer Patient Examination Glove

Changzhou Universal Medical Equipment CO. LTD.

The following data is part of a premarket notification filed by Changzhou Universal Medical Equipment Co. Ltd. with the FDA for Nitrile Glove Powder Free Blue.

Pre-market Notification Details

Device IDK210145
510k NumberK210145
Device Name:Nitrile Glove Powder Free Blue
ClassificationPolymer Patient Examination Glove
Applicant Changzhou Universal Medical Equipment CO. LTD. No 6 Xinxi Road Xinbei District,  CN 213000
ContactXiaohai Wan
CorrespondentRoxanne Dubois
R. Dubois Consulting, LLC 1399 Robnick Ct. Campbell,  CA  95008
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-21
Decision Date2021-04-21

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