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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 K150224
Device Name BLUE VINYL GLOVES POWDER FREE
Applicant
Zibo Sanying Trade Co., Ltd.
Xilv Village Fangzhen, Zhangdian District
Zibo,  CN 255000
Applicant Contact Jing Li
Correspondent
Beijing Believe Tech.Service Co., Ltd.
1-202, Build 3, Beijing New World, #5 Chaoyang Rd.,
Beijing,  CN
Correspondent Contact Ray Wang
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received02/02/2015
Decision Date 05/12/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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