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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K221718
Device Name Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)
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 Number878.4460
Classification Product Code
KGO  
Subsequent Product Code
LZC  
Date Received06/13/2022
Decision Date 09/24/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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