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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 K172923
Device Name Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue
Applicant
Top Glove Sdn. Bhd.
Lot 4968, Jalan Teratai, Batu 6
Off Jalan Meru
Klang,  MY 41050
Applicant Contact Noor Akilah Binti Saidin
Correspondent
Top Glove Sdn. Bhd.
Lot 4968, Jalan Teratai, Batu 6
Off Jalan Meru
Klang,  MY 41050
Correspondent Contact Noor Akilah Binti Saidin
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received09/25/2017
Decision Date 04/26/2018
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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