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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 K142862
Device Name POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).
Applicant
Careplus (M) SDN BHD
Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate,
70450 Seremban
Negeri Sembilan Darul Khusus,  MY
Applicant Contact Lim Kwee Shyan
Correspondent
Careplus (M) SDN BHD
Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate,
70450 Seremban
Negeri Sembilan Darul Khusus,  MY
Correspondent Contact Lim Kwee Shyan
Regulation Number880.6250
Classification Product Code
LZA  
Date Received10/01/2014
Decision Date 01/16/2015
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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