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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 K992810
Device Name HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE
Applicant
Hwa Teh Industrial Sdn. Bhd.
Lot 187, Sungai Dahar
Batang Berjuntai,  MY 45600
Applicant Contact K. KARUNAKARAN
Correspondent
Hwa Teh Industrial Sdn. Bhd.
Lot 187, Sungai Dahar
Batang Berjuntai,  MY 45600
Correspondent Contact K. KARUNAKARAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/20/1999
Decision Date 09/27/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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