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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 K201857
Device Name Powder Free Nitrile Examination Glove Black and Dual Color White-Blue
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 Bee Suan Khoo
Regulation Number880.6250
Classification Product Code
LZA  
Date Received07/06/2020
Decision Date 08/20/2021
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
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