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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 K220401
Device Name Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test Claim
Applicant
Riverstone Resources Sdn Bhd
Lot 20852, #119, Jalan Logam 7
Kamunting Raya Industrial Estate
Taiping,  MY 34600
Applicant Contact Suresh Kumar
Correspondent
Riverstone Resources Sdn Bhd
Lot 20852, #119, Jalan Logam 7
Kamunting Raya Industrial Estate
Taiping,  MY 34600
Correspondent Contact Suresh Kumar
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received02/11/2022
Decision Date 04/09/2022
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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