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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K181047
Device Name Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs
Applicant
Smart Glove Corporation Sdn.Bhd.
Lot 6487, Batu 5 3/4, Sementa, Jalan Kapar
Klang,  MY 42100
Applicant Contact Khon Pu Foo
Correspondent
Smart Glove Corporation Sdn.Bhd.
Lot 6487, Batu 5 3/4, Sementa, Jalan Kapar
Klang,  MY 42100
Correspondent Contact Khon Pu Foo
Regulation Number878.4460
Classification Product Code
KGO  
Date Received04/19/2018
Decision Date 01/09/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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