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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 K021220
Device Name NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Applicant
Siam Sempermed Corp., Ltd.
30798 Us Hwy. 19n
Palm Harbor,  FL  34684
Applicant Contact JOHN V CALHOUN
Correspondent
Siam Sempermed Corp., Ltd.
30798 Us Hwy. 19n
Palm Harbor,  FL  34684
Correspondent Contact JOHN V CALHOUN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received03/22/2002
Decision Date 06/06/2002
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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