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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 K180645
Device Name Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)
Applicant
Hartalega Sdn Bhd
C-G-9, Jalan Dataran Sd 1
Dataran Sd Pju 9
Bandar Sri Damansara,  MY 52200
Applicant Contact Mr. Kuan Kam Hon
Correspondent
Hartalega Sdn Bhd
#7, Kawasan Perusahaan Suria
Bestari Jaya,  MY 52200
Correspondent Contact Nural Aisyah Kong
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received03/12/2018
Decision Date 11/16/2018
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 Yes
Predetermined Change
Control Plan Authorized		 No
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