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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 K122102
Device Name POWER FREE VINYL EXAMINATION GLOVES
Applicant
Wang Tong Xinghua Co., Ltd.
West Of Guo Jing Rd.
Economic Development District
Xinghua,  CN 225700
Applicant Contact GUO YANG
Correspondent
Wang Tong Xinghua Co., Ltd.
West Of Guo Jing Rd.
Economic Development District
Xinghua,  CN 225700
Correspondent Contact GUO YANG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received07/16/2012
Decision Date 09/09/2013
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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