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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 K083931
Device Name SYNTHETIC POWDER-FREE EXAM VINYL GLOVES, YELLOW/WHITE
Applicant
Quantum Co., Ltd.
#2-3-18 Hua Sheng Yuan Park
Linzi
Shandong,  CN 255410
Applicant Contact LIJUAN WANG
Correspondent
Quantum Co., Ltd.
#2-3-18 Hua Sheng Yuan Park
Linzi
Shandong,  CN 255410
Correspondent Contact LIJUAN WANG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received12/05/2008
Decision Date 04/27/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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