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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 K992924
Device Name QTEXX, NON-CHLORINATED, POWDER FREE NITRILE EXAMINATION GLOVES, POLYMER-COATED
Applicant
Latexx Partners Bhd.
Pt. 5054, Kamunting Ind Estate
P.O. Box 9
Kamunting, Perak,  MY 34600
Applicant Contact LIM CHONG ENG
Correspondent
Latexx Partners Bhd.
Pt. 5054, Kamunting Ind Estate
P.O. Box 9
Kamunting, Perak,  MY 34600
Correspondent Contact LIM CHONG ENG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/30/1999
Decision Date 11/05/1999
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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