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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 K160562
Device Name Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
Applicant
Hartalega Snd. Bhd.
C-G-1, Jalan Dataran Sd1
Dataran Sd Pju 9
Bandar Sri Damansara,  MY 52200
Applicant Contact KUAN KAM HON
Correspondent
Hartalega Snd. Bhd.
10 E Scranton Ave., Suite 201
Lake Bluff,  IL  60044
Correspondent Contact H. Carl Jenkins
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received02/29/2016
Decision Date 10/13/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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