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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 K110338
Device Name POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Applicant
ZIBO YUECHUAN PLASTIC PRODUCTS CO., LTD.
12390 EAST END AVENUE
CHINO,  CA  91710
Applicant Contact FRANK LIU
Correspondent
ZIBO YUECHUAN PLASTIC PRODUCTS CO., LTD.
12390 EAST END AVENUE
CHINO,  CA  91710
Correspondent Contact FRANK LIU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received02/04/2011
Decision Date 04/19/2011
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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