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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 K180786
Device Name Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff
Applicant
HARTALEGA SDN. BHD.
Dataran Sd Pju 9
Bandar Sri Damansara,  MY 52200
Applicant Contact Kuan Kam Hon
Correspondent
HARTALEGA SDN. BHD.
No. 7, Kawasan Perusahaan Suria
Bestari Jaya,  MY 45600
Correspondent Contact Nurual Aisyah Kong
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received03/26/2018
Decision Date 11/02/2018
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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