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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 K013267
Device Name POWDER FREE (POLYMER COATED) NON CHLORINATED WHITE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICS
Applicant
Siam Sempermed Corp., Ltd.
30798 Us Hwy. 19n
Palm Harbor,  FL  34684
Applicant Contact KATIE LEVINSON
Correspondent
Siam Sempermed Corp., Ltd.
30798 Us Hwy. 19n
Palm Harbor,  FL  34684
Correspondent Contact KATIE LEVINSON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/01/2001
Decision Date 03/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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