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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 K201530
Device Name Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey)
Applicant
Hartalega Ngc Sdn. Bhd.
Kawasan Perindustrian Tanjung
Sepang,  MY 43900
Applicant Contact Kuan Mun Leong
Correspondent
Hartalega Ngc Sdn. Bhd.
Kawasan Perindustrian Tanjung
Sepang,  MY 43900
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
Predetermined Change
Control Plan Authorized		 No
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