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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 K120066
Device Name POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIAL
Applicant
Kossan Latex Industries(M)Sdn Bhd
Lot 6129,Jalan Haji Abdul
Manan, Off Jalan Meru
Klang, Selangor D.E.,  MY 41050
Applicant Contact CHO S FONG
Correspondent
Kossan Latex Industries(M)Sdn Bhd
Lot 6129,Jalan Haji Abdul
Manan, Off Jalan Meru
Klang, Selangor D.E.,  MY 41050
Correspondent Contact CHO S FONG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received01/09/2012
Decision Date 11/16/2012
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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