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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 K001715
Device Name POWDERED PATIENT EXAMINATION GLOVES, LATEX
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 Number880.6250
Classification Product Code
LYY  
Date Received06/05/2000
Decision Date 07/05/2000
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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