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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 K023915
Device Name STERILE POWDERED LATEX PATIENT EXAMINATION GLOVES
Applicant
Sanrea Healthcare Private Limited
Cochin Special Economic Zone
Kakkanad, Cochin
Kerala,  IN 682037
Applicant Contact JOSEPH J E PEREIRA
Correspondent
Sanrea Healthcare Private Limited
Cochin Special Economic Zone
Kakkanad, Cochin
Kerala,  IN 682037
Correspondent Contact JOSEPH J E PEREIRA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/25/2002
Decision Date 02/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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