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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 K991153
Device Name MEDTEXX POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTA\
Applicant
Medtexx Industries (Thai) Co. , Ltd.
200 Mu-4, Tambol Tachang
P.O. Box 38 Hatyai
Amphur Bangklam Songkhla,  TH 90110
Applicant Contact STEPHEN TAN CKENG KIM
Correspondent
Medtexx Industries (Thai) Co. , Ltd.
200 Mu-4, Tambol Tachang
P.O. Box 38 Hatyai
Amphur Bangklam Songkhla,  TH 90110
Correspondent Contact STEPHEN TAN CKENG KIM
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/06/1999
Decision Date 06/21/1999
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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