SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE

Vinyl Patient Examination Glove

CURON SCIENTIFIC CO., LTD

The following data is part of a premarket notification filed by Curon Scientific Co., Ltd with the FDA for Synthetic Vinyl Examination Gloves, Powder Free.

Pre-market Notification Details

Device IDK102337
510k NumberK102337
Device Name:SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE
ClassificationVinyl Patient Examination Glove
Applicant CURON SCIENTIFIC CO., LTD NO. 6-2 XING'AN ROAD E EAST LINQU Weifang,  CN 262600
ContactPeter Wang
CorrespondentPeter Wang
CURON SCIENTIFIC CO., LTD NO. 6-2 XING'AN ROAD E EAST LINQU Weifang,  CN 262600
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-18
Decision Date2010-11-08
Summary:summary

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