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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 K210990
Device Name Non-sterile Powder Free Nitrile Examination Gloves
Applicant
Rubberex Alliance Sdn Bhd
Lot 128201 Off 3/4 Mile, Jalan Bercham, Kawasan
Perindustrian Bercham
Ipoh,  MY 314000
Applicant Contact Sabri Abd Hamid
Correspondent
Mdi Consultants, Inc.
55 Northern Blvd.
Great Neck,  NY  11021
Correspondent Contact Aristotle Nafpliotis
Regulation Number880.6250
Classification Product Code
LZA  
Date Received04/02/2021
Decision Date 11/22/2021
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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