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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 K896489
Device Name TOYOSUYA LATEX EXAMINATION GLOVES
Applicant
TOYOSUYA SDN BHD
40A JALAN SS2/66
47300 PETALING JAYA
SELANGOR, MALAYSIA,  MY
Applicant Contact SIAU KIONG
Correspondent
TOYOSUYA SDN BHD
40A JALAN SS2/66
47300 PETALING JAYA
SELANGOR, MALAYSIA,  MY
Correspondent Contact SIAU KIONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/13/1989
Decision Date 12/20/1989
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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