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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 K140322
Device Name WHITE VINYL EXAM GLOVES POWDER FREE
Applicant
Shandong Dawei Medical Products Co., Ltd.
12390 E. End Ave.
Chino,  CA  91710
Applicant Contact SOPHIE HAO
Correspondent
Shandong Dawei Medical Products Co., Ltd.
12390 E. End Ave.
Chino,  CA  91710
Correspondent Contact SOPHIE HAO
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received02/10/2014
Decision Date 06/12/2014
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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