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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 K023515
Device Name PRE-POWDERED LATEX SURGEON'S GLOVES
Applicant
Sanrea Healthcare Private Limited
Cochin Special Economic Zone
Kakkanad, Cochin
Kerala,  IN 682037
Applicant Contact JOSE PAUL M
Correspondent
Sanrea Healthcare Private Limited
Cochin Special Economic Zone
Kakkanad, Cochin
Kerala,  IN 682037
Correspondent Contact JOSE PAUL M
Regulation Number878.4460
Classification Product Code
KGO  
Date Received10/21/2002
Decision Date 01/16/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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