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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 K090513
Device Name VINYL EXAMINATION GLOVE, POWDER FREE CLEAR (NON-COLORED)
Applicant
Shandong Huayue Glove Co., Ltd.
East Of Yifan/North Of Naqi Rd.
Zhangdian, Shandong,  CN
Applicant Contact JINYOU LIN
Correspondent
Shandong Huayue Glove Co., Ltd.
East Of Yifan/North Of Naqi Rd.
Zhangdian, Shandong,  CN
Correspondent Contact JINYOU LIN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received02/26/2009
Decision Date 05/08/2009
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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