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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 K212596
Device Name Sterile Latex Surgical 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. STE 114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number878.4460
Classification Product Code
KGO  
Date Received08/16/2021
Decision Date 03/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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