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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 K183536
Device Name Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
Applicant
Hartalega NGC Sdn. Bhd.
Kawasan Perindustrian Tanjung
Sepang,  MY 43900
Applicant Contact Kuan Mun Leong
Correspondent
Hartalega NGC Sdn. Bhd.
Dataran Sd Pju9
Bandar Sri Damansara,  MY 52200
Correspondent Contact Nurul Aisyah Kong
Regulation Number878.4460
Classification Product Code
KGO  
Date Received12/19/2018
Decision Date 08/16/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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