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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 K223437
Device Name Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)
Applicant
Hartalega NGC Sdn. Bhd.
# 1, Persiaran Tanjung
Kawasan Perindustrian Tanjung
Sepang,  MY 43900
Applicant Contact Kuan Mun Leong
Correspondent
Hartalega NGC Sdn. Bhd.
# 1, Persiaran Tanjung
Kawasan Perindustrian Tanjung
Sepang,  MY 43900
Correspondent Contact Nurul Aisyah Kong
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received11/14/2022
Decision Date 05/17/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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