POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES

Patient Examination Glove, Specialty

SHEN WEI (USA), INC.

The following data is part of a premarket notification filed by Shen Wei (usa), Inc. with the FDA for Powder Free Sterile Latex Exam Radiation Attenuation Gloves.

Pre-market Notification Details

Device IDK121811
510k NumberK121811
Device Name:POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES
ClassificationPatient Examination Glove, Specialty
Applicant SHEN WEI (USA), INC. 33278 CENTRAL AVE., SUITE 102 Union City,  CA  94587
ContactAlbert Li
CorrespondentAlbert Li
SHEN WEI (USA), INC. 33278 CENTRAL AVE., SUITE 102 Union City,  CA  94587
Product CodeLZC  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-06-20
Decision Date2012-11-21

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