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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 K201531
Device Name Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Applicant
Hartalega SDN. BHD.
Dataran SD PJU9
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 Nurul Aisyah Kong
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   QDO  
Date Received06/08/2020
Decision Date 08/05/2020
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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