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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 K991474
Device Name HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED MULTI-PLY EXAMINATION GLOVE, (NATURAL LATEX LAMINATED WITH NITRILE, EXTERNA
Applicant
Pamitex Industries Sdn Bhd
Batu 2 1/2, Jalan Rasah
Seremban, N.S.,  MY 70300
Applicant Contact AZMAN ISMAIL
Correspondent
Pamitex Industries Sdn Bhd
Batu 2 1/2, Jalan Rasah
Seremban, N.S.,  MY 70300
Correspondent Contact AZMAN ISMAIL
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/27/1999
Decision Date 10/06/1999
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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