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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 K152542
Device Name Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs
Applicant
Riverstone Resources Sdn Bhd
Lot 55 & 56, No13, Jalan Jasmin 2,
Kawasan Perindustrian Bukit Beruntung
Bukit Beruntung,  MY 48300
Applicant Contact SURESH KUMAR
Correspondent
Riverstone Resources Sdn Bhd
Lot 55 & 56, No13, Jalan Jasmin 2,
Kawasan Perindustrian Bukit Beruntung
Bukit Beruntung,  MY 48300
Correspondent Contact SURESH KUMAR
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received09/04/2015
Decision Date 12/24/2015
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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