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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K143477
Device Name Nitrile Patient Examination gloves, Powderfree, Blue color
Applicant
Primus Gloves Pvt Limited
Plot No: 14-A, Cochin Special Economic Zone, Kakkanad
Cochin,  IN 682037
Applicant Contact JOSE PAUL M
Correspondent
Primus Gloves Pvt Limited
Plot No: 14-A, Cochin Special Economic Zone, Kakkanad
Cochin,  IN 682037
Correspondent Contact JOSE PAUL M
Regulation Number880.6250
Classification Product Code
LZA  
Date Received12/05/2014
Decision Date 04/14/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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