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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 K954880
Device Name LATEX PATIENT EXAMINATION GLOVE (POWDERFREE/HYPOALLERGENIC) (MODIFICATION)
Applicant
SIAM SEMPERMED CORP. LTD.
26 LEEWARD ISLAND
CLEARWATER,  FL  34630
Applicant Contact DON MORRIS
Correspondent
SIAM SEMPERMED CORP. LTD.
26 LEEWARD ISLAND
CLEARWATER,  FL  34630
Correspondent Contact DON MORRIS
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/17/1995
Decision Date 11/15/1995
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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