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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K122363
Device Name NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
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
LZA  
Date Received08/06/2012
Decision Date 09/10/2012
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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