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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 K123590
Device Name VINYL EXAMINATION POWDER FREE GLOVES, CLEAR
Applicant
Weilin Plastic and Rubber Products Co., Ltd.
12390 E. End Ave.
Chino,  CA  91710
Applicant Contact LING ZHU
Correspondent
Weilin Plastic and Rubber Products Co., Ltd.
12390 E. End Ave.
Chino,  CA  91710
Correspondent Contact LING ZHU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received11/21/2012
Decision Date 06/17/2013
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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