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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K904769
Device Name SENSITOUCH
Applicant
Ansell Intl.
Lot 80, Air Keroh Ind. Est.
Melaka,  MT 75150
Applicant Contact PAUL CACIOLI
Correspondent
Ansell Intl.
Lot 80, Air Keroh Ind. Est.
Melaka,  MT 75150
Correspondent Contact PAUL CACIOLI
Regulation Number878.4460
Classification Product Code
KGO  
Date Received10/22/1990
Decision Date 01/28/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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