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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 K170612
Device Name STERILE VINYL EXAMINATION 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 Number880.6250
Classification Product Code
LYZ  
Date Received03/01/2017
Decision Date 10/23/2017
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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