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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. STE 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
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