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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 K170515
Device Name Sterile Nitrile Surgical Gloves, Powder-free
Applicant
Primus Gloves Pvt Limited
Plot No 14a, Cochin Special Economic Zone, Kakkanad
Cochin,  IN 682037
Applicant Contact Jose Paul M
Correspondent
Primus Gloves Pvt Limited
Plot No 14a, Cochin Special Economic Zone, Kakkanad
Cochin,  IN 682037
Correspondent Contact Jose Paul M
Regulation Number878.4460
Classification Product Code
KGO  
Date Received02/21/2017
Decision Date 06/09/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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