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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
Predetermined Change
Control Plan Authorized		 No
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