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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)
Applicant
Ur Industry Sdn Bhd
180, Jalan Murni 9, Taman Perindustrian Murni
Senai,  MY 81400
Applicant Contact Chua Song Han
Correspondent
Integrated Assessment Services Pvt, Ltd.
# 1919-1920, Bldg. D3, Minjie Plz., Shuixi Rd.,
Chennai,  IN 600040
Correspondent Contact A.C. Thirumaran
Regulation Number880.6250
Classification Product Code
LZA  
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
Predetermined Change
Control Plan Authorized		 No
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