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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K020044
Device Name VINYL EXAMINATION GLOVES STERILE POWEDERED
Applicant
Primus Gloves Private , Ltd.
Plot No:14-A Cochin Special
Economic Zone
Kakkanad, Kochi, Kerala,  IN 682 030
Applicant Contact JOSEPH J E PEREIRA
Correspondent
Primus Gloves Private , Ltd.
Plot No:14-A Cochin Special
Economic Zone
Kakkanad, Kochi, Kerala,  IN 682 030
Correspondent Contact JOSEPH J E PEREIRA
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received01/07/2002
Decision Date 02/26/2002
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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