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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 K090412
Device Name POWDER FREE NITRILE EXAMINATION GLOVES (PINK, GREEN, ORANGE,WHITE).
Applicant
Gx Corporation Sdn Bhd
Lot 6487, Batu 5 3/4
Sementa, Jalan Kapar
Klang, Selangor,  MY 42100
Applicant Contact FOO KHON PU
Correspondent
Gx Corporation Sdn Bhd
Lot 6487, Batu 5 3/4
Sementa, Jalan Kapar
Klang, Selangor,  MY 42100
Correspondent Contact FOO KHON PU
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received02/18/2009
Decision Date 06/01/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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