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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 K171171
Device Name KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)
Applicant
Koon Seng Sdn Bhd
Ptd 16058 Kawasan Perindustrian Tangkak
Jalan Muar,  MY 84900
Applicant Contact Koon Seng Sdn. Bhd.
Correspondent
Mdi Consultants, Inc.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact Jigar Shah
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received04/21/2017
Decision Date 02/22/2018
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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