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U.S. Department of Health and Human Services

Devices@FDA
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Device Classification Name surgeon's gloves
510(k) Number K200897
Device Name Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)
Applicant
Hartalega SDN. BHD.
Dataran SD PJU9
Bandar Sri Damansara,  MY 52200
Applicant Contact Kuan Kam Hon
Correspondent
Hartalega SDN. NHD
NO. 7, Kawasan Perusahaan Suria
Bestari Jaya,  MY 45600
Correspondent Contact Nurul Aisyah Kong
Regulation Number878.4460
Classification Product Code
KGO  
Subsequent Product Code
LZC  
Date Received04/03/2020
Decision Date 06/01/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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