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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 K190725
Device Name Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White
Applicant
Riverstone Resources Sdn Bhd
Lot 56, No 15, Jalan Jasmin 2
Bukit Beruntung,  MY 48300
Applicant Contact Suresh Kumar
Correspondent
Riverstone Resources Sdn Bhd
Lot 56, No 15, Jalan Jasmin 2
Bukit Beruntung,  MY 48300
Correspondent Contact Suresh Kumar
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received03/20/2019
Decision Date 12/17/2019
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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