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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 K122920
Device Name POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
Applicant
HEBEI LEADER PLASTIC CO., LTD
ROOM 1606 BLDG. 1. JIANXIANG YUAN
NO. 209 BEI SI HUAN ZHO
BEIJING,  CN 100083
Applicant Contact CHU XIAOAN
Correspondent
HEBEI LEADER PLASTIC CO., LTD
ROOM 1606 BLDG. 1. JIANXIANG YUAN
NO. 209 BEI SI HUAN ZHO
BEIJING,  CN 100083
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/24/2012
Decision Date 11/30/2012
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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