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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 K984229
Device Name LATEX EXAMINATION GLOVES (POWDERED)
Applicant
Sama Kejuruteraan Sdn.Bhd.
Taman Bukit Belimbing
43300 Balakong
Selangor D.E.,  MY 43300
Applicant Contact KUAN TECK
Correspondent
Sama Kejuruteraan Sdn.Bhd.
Taman Bukit Belimbing
43300 Balakong
Selangor D.E.,  MY 43300
Correspondent Contact KUAN TECK
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/25/1998
Decision Date 05/17/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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