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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 K955889
Device Name POWDERFREE LATEX EXAMINATION GLOVES
Applicant
Pantai Utama Sdn. Bhd.
Lot Pt. 7178, Balakong
N/ Village
Seri Kembangan, Selangor,  MY 43300
Applicant Contact LIM LEE AIK
Correspondent
Pantai Utama Sdn. Bhd.
Lot Pt. 7178, Balakong
N/ Village
Seri Kembangan, Selangor,  MY 43300
Correspondent Contact LIM LEE AIK
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/29/1995
Decision Date 04/26/1996
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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