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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 K111133
Device Name NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM (50 MG OR LESS)
Applicant
Ssc Surat Thani
13900 49th St. N.
Clearwater,  FL  33762
Applicant Contact WILLIAM E HARRIS , III
Correspondent
Ssc Surat Thani
13900 49th St. N.
Clearwater,  FL  33762
Correspondent Contact WILLIAM E HARRIS , III
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/22/2011
Decision Date 06/24/2011
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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