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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 K172864
Device Name Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
Applicant
Maxter Glove Manufacturing Sdn Bhd
Lot 6070, Jalan Haji Abdul Manah
6th Miles Off Jalan Meru
Klang,  MY 41050
Applicant Contact Yap Peak Geeh
Correspondent
Maxter Glove Manufacturing Sdn Bhd
Lot 6070, Jalan Haji Abdul Manah
6th Miles Off Jalan Meru
Klang,  MY 41050
Correspondent Contact Yap Peak Geeh
Regulation Number880.6250
Classification Product Code
LZC  
Date Received09/20/2017
Decision Date 05/02/2018
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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