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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K893166
Device Name LATEX EXAMINATION GLOVES
Applicant
Gulfwin Holding Sdn. Bhd.
Wisma Binadon, Lengkongan Hish
Amudin Kawasan 20, 42000 Port
Klang, S.D.E. Malaysia,  MY
Applicant Contact KENG BENG
Correspondent
Gulfwin Holding Sdn. Bhd.
Wisma Binadon, Lengkongan Hish
Amudin Kawasan 20, 42000 Port
Klang, S.D.E. Malaysia,  MY
Correspondent Contact KENG BENG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/14/1989
Decision Date 06/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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