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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K981159
Device Name PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES
Applicant
Latexx Partners Bhd.
P.O. Box 9
Taiping Perak,  MY 34600
Applicant Contact GOH SEE KHEK
Correspondent
Latexx Partners Bhd.
P.O. Box 9
Taiping Perak,  MY 34600
Correspondent Contact GOH SEE KHEK
Regulation Number880.6250
Classification Product Code
LZA  
Date Received03/31/1998
Decision Date 06/01/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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