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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 K913215
Device Name SURGIFIT STERILE SURGICAL GLOVES
Applicant
Hevealactics Intl. Sdn Bhd
Lot 730 Jalan Sungai Rasa
Klang, Selangor Darul Ehsan,  MY 41300
Applicant Contact KI KIM
Correspondent
Hevealactics Intl. Sdn Bhd
Lot 730 Jalan Sungai Rasa
Klang, Selangor Darul Ehsan,  MY 41300
Correspondent Contact KI KIM
Regulation Number878.4460
Classification Product Code
KGO  
Date Received07/19/1991
Decision Date 09/23/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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