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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 K153028
Device Name Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue
Applicant
ZIBO HUIYING MEDICAL PRODUCTS, CO. LTD.
NO. 3 DA WU ROAD
LINZI,  CN 255400
Applicant Contact Fufang Wang
Correspondent
BASIC MEDICAL INDUSTRIES, INC.
12390 East End Ave
Chino,  CA  91710
Correspondent Contact Sophie Hao
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received10/16/2015
Decision Date 02/05/2016
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
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