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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 K212584
Device Name Blue Nitrile Examination Gloves Powder Free
Applicant
Amazing Rubber Products Pvt Ltd
Plot No 14c, Cochin Special Economic Zone
Cochin,  IN 682037
Applicant Contact Jayasankar S
Correspondent
Liberty Management Group Ltd.
75 Executive Dr. STE114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/16/2021
Decision Date 05/28/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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