SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)

Vinyl Patient Examination Glove

PREMIER MEDICAL GLOVES FACTORY

The following data is part of a premarket notification filed by Premier Medical Gloves Factory with the FDA for Synthetic Vinyl Examination Gloves, Powder Free (and Multiple Labels).

Pre-market Notification Details

Device IDK111297
510k NumberK111297
Device Name:SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)
ClassificationVinyl Patient Examination Glove
Applicant PREMIER MEDICAL GLOVES FACTORY NO. 8-2, XING'AN RD., DONGCHENG, LINQU Weifang, Shandong,  CN 262600
ContactLiang Zhao
CorrespondentLiang Zhao
PREMIER MEDICAL GLOVES FACTORY NO. 8-2, XING'AN RD., DONGCHENG, LINQU Weifang, Shandong,  CN 262600
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-05-09
Decision Date2011-06-16

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