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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K103772
Device Name VINYL EXAMINATION GLOVE POWDER FREE (CLEAR, NON-COLRED) /YELLOW/WHITE)
Applicant
Advanced Medical Devices Factory
# 8-1 Xing'An Rd.
East Linqu
Weifang, Shandong,  CN 262600
Applicant Contact XINGYUAN WANG
Correspondent
Advanced Medical Devices Factory
# 8-1 Xing'An Rd.
East Linqu
Weifang, Shandong,  CN 262600
Correspondent Contact XINGYUAN WANG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received12/27/2010
Decision Date 02/25/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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