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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 K222349
Device Name JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)
Applicant
JR Engineering & Medical Technologies (M) SDN.BHD.
Lot 8 &10, Jalan Zurah 3 & Lot 1&3,
Jalan Zurah 3A/1, Pusat Perindustrian 2,
Hulu Selangor,  MY 44200
Applicant Contact Ganesan Subramaniam
Correspondent
Liberty Management Group Ltd.
75 Executive Dr. STE114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/03/2022
Decision Date 10/21/2022
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
Predetermined Change
Control Plan Authorized		 No
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