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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 K162095
Device Name Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)
Applicant
Yty Industry (Manjung) Sdn Bhd
Lot 1422-1424
Batu 10 Lekir
Sitiawan,  MY 32020
Applicant Contact Punitha Samy
Correspondent
Yty Industry (Manjung) Sdn Bhd
Lot 1422-1424
Batu 10 Lekir
Sitiawan,  MY 32020
Correspondent Contact Punitha Samy
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received07/28/2016
Decision Date 11/02/2016
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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