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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 K022347
Device Name MEDTEXX GREEN COLOUR POWDERED NITRILE RUBBER EXAMINATION GLOVES
Applicant
LATEXX MANUFACTURING SDN.BHD.
PT. 5054, P.O. BOX 9
KAMUNTING INDUSTRIAL ESTATE
TAIPING, PERAK,  MY 34600
Applicant Contact TEOH CHOH SHEE
Correspondent
LATEXX MANUFACTURING SDN.BHD.
PT. 5054, P.O. BOX 9
KAMUNTING INDUSTRIAL ESTATE
TAIPING, PERAK,  MY 34600
Correspondent Contact TEOH CHOH SHEE
Regulation Number880.6250
Classification Product Code
LZA  
Date Received07/19/2002
Decision Date 08/15/2002
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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