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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 K221169
Device Name JR MEDIC Nitrile Examination Gloves Powder Free- Black
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
Liberty Management Group Ltd.
75 Executive Drive, Ste 114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number880.6250
Classification Product Code
Date Received04/22/2022
Decision Date 10/25/2022
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