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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Glove, Specialty
510(k) Number K212827
Device Name Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs
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 Number880.6250
Classification Product Code
LZC  
Subsequent Product Codes
LZA   OPJ  
Date Received09/03/2021
Decision Date 12/06/2021
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
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