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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 K896251
Device Name HWA TEH EXAMINATION GLOVES
Applicant
Hwa Teh Industrial Sdn. Bhd.
16635 Valley View
Cerritos,  CA  91070
Applicant Contact BEN CHANG
Correspondent
Hwa Teh Industrial Sdn. Bhd.
16635 Valley View
Cerritos,  CA  91070
Correspondent Contact BEN CHANG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/30/1989
Decision Date 11/21/1989
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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