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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 K230958
Device Name First Glove Blue Nitrile Examination Gloves Powder Free
Applicant
First Glove Sdn. Bhd.
Unit 23-2, Level 23, Binjai 8, No. 2, Lorong Binjai
Kuala Lumpur,  MY 50450
Applicant Contact Dean Segal
Correspondent
Liberty Management Group Ltd.
75 Executive Dr. Ste 114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number880.6250
Classification Product Code
LZA  
Date Received04/04/2023
Decision Date 05/30/2023
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
Predetermined Change
Control Plan Authorized		 No
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