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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 K211816
Device Name Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Applicant
Brightway Holdings Sdn. Bhd.
Lot 1559, Jalan Istimewa, Batu Belah
Klang,  MY 42100
Applicant Contact G. Baskaran
Correspondent
Brightway Holdings Sdn. Bhd.
Lot 1559, Jalan Istimewa, Batu Belah
Klang,  MY 42100
Correspondent Contact Ganesh Subramaniam
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received06/11/2021
Decision Date 11/02/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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