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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 K002818
Device Name NIRTRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDERED, NON STERILE
Applicant
Siam Sempermed Corp., Ltd.
30798 Us Hwy. 19n
Palm Harbor,  FL  34684
Applicant Contact WILLIAM HARRIS
Correspondent
Siam Sempermed Corp., Ltd.
30798 Us Hwy. 19n
Palm Harbor,  FL  34684
Correspondent Contact WILLIAM HARRIS
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/04/2000
Decision Date 11/29/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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