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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 K183354
Device Name Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate
Applicant
Gx Corporation Sdn Bhd
Lot 6491 Batu 5 3/4, Sementa Jalan Kapar
Klang,  MY 42100
Applicant Contact Khon Pu Foo
Correspondent
Gx Corporation Sdn Bhd
Lot 6491 Batu 5 3/4, Sementa Jalan Kapar
Klang,  MY 42100
Correspondent Contact Foo Khon Pu
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   QDO  
Date Received12/03/2018
Decision Date 06/20/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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