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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K071322
Device Name POWDER FREE LATEX EXAMINATION GLOVES
Applicant
Quality Gallant Sdn. Bhd.
Lot 1874, Jalan Kampung Dew
Simpang Halt
Taiping, Perak,  MY 34700
Applicant Contact SEAH B HOON
Correspondent
Quality Gallant Sdn. Bhd.
Lot 1874, Jalan Kampung Dew
Simpang Halt
Taiping, Perak,  MY 34700
Correspondent Contact SEAH B HOON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/10/2007
Decision Date 07/13/2007
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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