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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 K102160
Device Name STRETCH VINYL EXAMINATION GLOVE POWDER FREE
Applicant
Shandong Blue Sail Innovation Co., Ltd.
East Side Of Xing'An Rd.,
Dongcheng St. Offie, Linqu
Weifang, Shandong,  CN 262600
Applicant Contact YONGCHEN ZHANG
Correspondent
Shandong Blue Sail Innovation Co., Ltd.
East Side Of Xing'An Rd.,
Dongcheng St. Offie, Linqu
Weifang, Shandong,  CN 262600
Correspondent Contact YONGCHEN ZHANG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received08/02/2010
Decision Date 10/04/2010
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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