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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 K010803
Device Name POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR
Applicant
Hwa Teh Industrial Sdn. Bhd.
Lot 187, Sungai Dahar
Batang Berjuntai,  MY 45600
Applicant Contact ABDUL HALIM ARSHAD
Correspondent
Hwa Teh Industrial Sdn. Bhd.
Lot 187, Sungai Dahar
Batang Berjuntai,  MY 45600
Correspondent Contact ABDUL HALIM ARSHAD
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/16/2001
Decision Date 05/11/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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