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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 K081907
Device Name NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 MICROGRAMS OR LESS)
Applicant
Siam Sempermed Corp., Ltd.
13900 49th St. N.
Clearwater,  FL  33762
Applicant Contact WILLIAM E HARRIS
Correspondent
Siam Sempermed Corp., Ltd.
13900 49th St. N.
Clearwater,  FL  33762
Correspondent Contact WILLIAM E HARRIS
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/03/2008
Decision Date 09/03/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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