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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 K981975
Device Name LATEX PATIENT EXAMINATION GLOVE POWDERFREE (BLUE COLOR) POLYMER COATED
Applicant
SIAM SEMPERMED CORP. LTD.
30798 US HWY 19 NORTH
PALM HARBOR,  FL  34684
Applicant Contact DON MORRIS
Correspondent
SIAM SEMPERMED CORP. LTD.
30798 US HWY 19 NORTH
PALM HARBOR,  FL  34684
Correspondent Contact DON MORRIS
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/05/1998
Decision Date 11/20/1998
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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