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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder-Free Polychloroprene Patient Examination Glove
510(k) Number K211758
Device Name Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)
Applicant
Hartalega NGC Sdn. Bhd.
# 1 Persiaran Tanjung
Sepang,  MY 43900
Applicant Contact Kuan Mun Leong
Correspondent
Hartalega NGC Sdn. Bhd.
# 1 Persiaran Tanjung
Sepang,  MY 43900
Correspondent Contact Nurul Aisyah Kong
Regulation Number880.6250
Classification Product Code
OPC  
Subsequent Product Code
LZC  
Date Received06/07/2021
Decision Date 08/03/2021
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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