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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 K141613
Device Name GOLDENLINE POWDER-FREE WHITE VINYL PATIENT EXAMINATION GLOVES
Applicant
ZIBO GOLDENLINE PLASTIC PRODUCT CO., LTD
ROOM 1606 BLDG I JIANZIANG YUAN NO. 209
BEI SI HUAN ZHONG ROAD, HAIDIAN DIS
BEIJING,  CN 100083
Applicant Contact CHU XIAOAN
Correspondent
ZIBO GOLDENLINE PLASTIC PRODUCT CO., LTD
ROOM 1606 BLDG I JIANZIANG YUAN NO. 209
BEI SI HUAN ZHONG ROAD, HAIDIAN DIS
BEIJING,  CN 100083
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received06/16/2014
Decision Date 12/04/2014
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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