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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 K142858
Device Name POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (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 02/09/2015
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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