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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 K993621
Device Name HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MIC
Applicant
Pamitex Industries Sdn Bhd
2 1/2 Miles, Jalan Rasah
Seremban, Nageri Sembilan
Darul Khusus,  MY 70300
Applicant Contact SAID AWANG
Correspondent
Pamitex Industries Sdn Bhd
2 1/2 Miles, Jalan Rasah
Seremban, Nageri Sembilan
Darul Khusus,  MY 70300
Correspondent Contact SAID AWANG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/26/1999
Decision Date 12/29/1999
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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