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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 K102902
Device Name RUBBERCARE POWDER FREE LATEX EXAMINATION GLOVE, BLUE COLOR
Applicant
Rubbercare Protection Products Sdn Bhd
Off Jalan Senawang Empat
Senawang Industrial Estate
Seremban, Negeri Sembilan,  MY 70450
Applicant Contact LIM KWEE SHYAN
Correspondent
Rubbercare Protection Products Sdn Bhd
Off Jalan Senawang Empat
Senawang Industrial Estate
Seremban, Negeri Sembilan,  MY 70450
Correspondent Contact LIM KWEE SHYAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/30/2010
Decision Date 04/22/2011
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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