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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 K981767
Device Name QTEXX POWDERFREE LATEX EXAMINATION GLOVES
Applicant
Latexx Partners Bhd.
P.O. Box 9
Taiping Perak,  MY 34600
Applicant Contact GOH S KHEK
Correspondent
Latexx Partners Bhd.
P.O. Box 9
Taiping Perak,  MY 34600
Correspondent Contact GOH S KHEK
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/19/1998
Decision Date 06/11/1998
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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