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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K152593
Device Name LATEX EXAMINATION GLOVE POWDER FREE
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
LYY  
Date Received09/10/2015
Decision Date 02/25/2016
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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