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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 K081592
Device Name POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES
Applicant
Quality Gallant Sdn. Bhd.
Lot 1874, Jalan Kampung Dew
Simpang Halt
Taiping, Perak,  MY 34700
Applicant Contact SEAH BEE HOON
Correspondent
Quality Gallant Sdn. Bhd.
Lot 1874, Jalan Kampung Dew
Simpang Halt
Taiping, Perak,  MY 34700
Correspondent Contact SEAH BEE HOON
Regulation Number880.6250
Classification Product Code
LZA  
Date Received06/06/2008
Decision Date 12/03/2008
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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