ALCATRON AND / OR MULTIPLE BRAND

Vinyl Patient Examination Glove

ALCATRON GLOVES FACTORY

The following data is part of a premarket notification filed by Alcatron Gloves Factory with the FDA for Alcatron And / Or Multiple Brand.

Pre-market Notification Details

Device IDK112222
510k NumberK112222
Device Name:ALCATRON AND / OR MULTIPLE BRAND
ClassificationVinyl Patient Examination Glove
Applicant ALCATRON GLOVES FACTORY NO. 12-1, XING'AN RD EAST LINQU, WEIFANG Shandong,  CN 262600
ContactShuqin Gao
CorrespondentShuqin Gao
ALCATRON GLOVES FACTORY NO. 12-1, 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 Received2011-08-02
Decision Date2011-10-27

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