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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 K171279
Device Name Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves
Applicant
Top Glove SDN BHD
Lot 4968, Jalan Teratai, Batu 6, Off Jalan Meru
Klang,  MY 41050
Applicant Contact Noor Akilah Bt Saidin
Correspondent
Top Glove SDN BHD
Lot 4968, Jalan Teratai, Batu 6, Off Jalan Meru
Klang,  MY 41050
Correspondent Contact Noor Akilah Bt Saidin
Regulation Number878.4460
Classification Product Code
KGO  
Subsequent Product Code
LZC  
Date Received05/01/2017
Decision Date 10/12/2017
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
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