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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 K170686
Device Name Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs
Applicant
Brightway Holdings Sdn. Bhd.
Lot 1559, Jalan Istimewa, Batu Belah
Klang,  MY 42100
Applicant Contact G. Baskaran
Correspondent
Truscott Medsci Associates, LLC
180 Burkemeade Ct.
Roswell,  GA  30075
Correspondent Contact Wava Truscott
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received03/07/2017
Decision Date 07/14/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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