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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 K113837
Device Name POWDER FREE VINYL PATIENT EXAMINATION GLOVES
Applicant
HEBEI CHANGSHENG PLASTIC PRODUCTS CO., LTD.
NO 99, HUANGJIN AVENUE,
JULU COUNTY
XINGTAI, HEBEI PROVINCE,  CN 055250
Applicant Contact RICHARD LU
Correspondent
HEBEI CHANGSHENG PLASTIC PRODUCTS CO., LTD.
NO 99, HUANGJIN AVENUE,
JULU COUNTY
XINGTAI, HEBEI PROVINCE,  CN 055250
Correspondent Contact RICHARD LU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received12/28/2011
Decision Date 04/27/2012
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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