SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE

Vinyl Patient Examination Glove

INMED GLOVES FACTORY

The following data is part of a premarket notification filed by Inmed Gloves Factory with the FDA for Synthetic Vinyl Examination Glove Powder Free.

Pre-market Notification Details

Device IDK111857
510k NumberK111857
Device Name:SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE
ClassificationVinyl Patient Examination Glove
Applicant INMED GLOVES FACTORY 10-2 XING'AN RD. EAST, LINQU, Weifang, Shandong,  CN 262600
ContactXiaobing Li
CorrespondentXiaobing Li
INMED GLOVES FACTORY 10-2 XING'AN RD. EAST, LINQU, Weifang, Shandong,  CN 262600
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-30
Decision Date2011-09-21

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