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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 K222531
Device Name Synthetic Polymer Glove - Polyethylene (Black)
UR Industry SDN BHD
180, Jalan Murni 9, Taman Perindustrian Murni
Senai,  MY 81400
Applicant Contact Chua Song Han
Integrated Assessment Services Pvt Ltd
No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road,
Chennai,  IN 600040
Correspondent Contact A.C. Thirumaran
Regulation Number880.6250
Classification Product Code
Date Received08/22/2022
Decision Date 01/22/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No