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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 K093263
Device Name STRETCH VINYL EXAMINATION GLOVE, POWDER FREE, YELLOW/WHITE
Applicant
Qingdao Lang Hui Import & Export Co., Ltd.
Shandong International Trade
Mansion 51 Taiping
Qingdao, Shandong,  CN 266000
Applicant Contact MARSHAL MA
Correspondent
Qingdao Lang Hui Import & Export Co., Ltd.
Shandong International Trade
Mansion 51 Taiping
Qingdao, Shandong,  CN 266000
Correspondent Contact MARSHAL MA
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received10/19/2009
Decision Date 04/30/2010
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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