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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 K160560
Device Name Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
Applicant
HARTALEGA SDN BHD
C-G-9 JALAN DATARAN
SD1 DATARAN SD PJU 9
BANDAR SERI DAMANSARA,  MY 52200
Applicant Contact KUAN KAM HON
Correspondent
HARTALEGA SDN BHD
NO. 7, KAWASAN PERUSAHAAN
SURIA
BESTARI JAYA,  MY 45600
Correspondent Contact NURUL AISYAH KONG
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received02/29/2016
Decision Date 08/04/2016
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
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