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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 K171743
Device Name Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination Gloves
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 Number880.6250
Classification Product Code
LZA  
Date Received06/12/2017
Decision Date 11/17/2017
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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