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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Glove, Specialty
510(k) Number K162858
Device Name NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST
Applicant
Careplus (M) Sdn Bhd
Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate
Seremban,  MY 70450
Applicant Contact LIM KWEE SHYAN
Correspondent
Careplus (M) Sdn Bhd
Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate
Seremban,  MY 70450
Correspondent Contact LIM KWEE SHYAN
Regulation Number880.6250
Classification Product Code
LZC  
Date Received10/12/2016
Decision Date 07/24/2017
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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