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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name polymer patient examination glove
510(k) Number K131440
Device Name POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
Applicant
HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD
5 CAREY STREET
PENNINGTON,  NJ  08534
Applicant Contact CHARLES SHEN
Correspondent
HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD
5 CAREY STREET
PENNINGTON,  NJ  08534
Correspondent Contact CHARLES SHEN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/20/2013
Decision Date 09/25/2013
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 Yes
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