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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 K222350
Device Name Sterile Nitrile Surgical Gloves Powder Free
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., Suite 114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number878.4460
Classification Product Code
KGO  
Date Received08/03/2022
Decision Date 04/13/2023
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
Predetermined Change
Control Plan Authorized		 No
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