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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 K230601
Device Name Blue Nitrile Examination Gloves Powder Free
Applicant
Latrile Gloves Private Limited
Plot No : B5 - Sipcot Induatrial Complex,
8th Main road, Pallapatti Village, Nilakottai Taluk
Dindigul,  IN 624201
Applicant Contact M Ragu
Correspondent
Liberty Management Group Ltd.
75 Executive Dr. STE114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number880.6250
Classification Product Code
LZA  
Date Received03/03/2023
Decision Date 05/28/2023
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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