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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 K150103
Device Name Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs
Applicant
Hartalega Sdn Bhd
C-G-9, Jalan Dataran Sd 1
Dataran Sd Pju 9
Bandar Sri Damansara,  MY 52200
Applicant Contact Kuan Kam Hon
Correspondent
Hartalega Sdb. Bhd.
# 7 Kawasan Perusahaan Suria
Bestari Jaya,  MY 45600
Correspondent Contact Nurul Aisyah Kong Bt Abdullah
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received01/20/2015
Decision Date 04/23/2015
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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