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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 K190080
Device Name Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)
Applicant
Comfort Rubber Gloves Industries Sdn. Bhd.
Lot 821
Jalan Matang
Matang,  MY 34750
Applicant Contact Chan Yew Men
Correspondent
Comfort Rubber Gloves Industries Sdn. Bhd.
Lot 821
Jalan Matang
Matang,  MY 34750
Correspondent Contact Chan Yew Men
Regulation Number880.6250
Classification Product Code
LZA  
Date Received01/16/2019
Decision Date 06/27/2019
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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