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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 K000896
Device Name POWDERFREE LATEX SURGEON'S GLOVES WITH PROTIEN LABELING CLAIM (50 MOCROGRAMS OR LESS
Applicant
Fitco Dipped Products Pvt., Ltd.
14-A Cochin Export Processing
Zone, Kakkanand, Kochi
Kerala,  IN 682 030
Applicant Contact JOSEPH J E PEREIRA
Correspondent
Fitco Dipped Products Pvt., Ltd.
14-A Cochin Export Processing
Zone, Kakkanand, Kochi
Kerala,  IN 682 030
Correspondent Contact JOSEPH J E PEREIRA
Regulation Number878.4460
Classification Product Code
KGO  
Date Received03/20/2000
Decision Date 05/03/2000
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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