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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 K961634
Device Name NIL - POWDER-FREE LATEX EXAMINATION GLOVES
Applicant
Hl Rubber Products Sdn Bhd
7th Floor, Balai Felda
Jalan Gurney 1
Kuala Lumpur,  MY 54000
Applicant Contact YUNUS LATIF
Correspondent
Hl Rubber Products Sdn Bhd
7th Floor, Balai Felda
Jalan Gurney 1
Kuala Lumpur,  MY 54000
Correspondent Contact YUNUS LATIF
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/29/1996
Decision Date 06/16/1997
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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