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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 K050530
Device Name POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET, PINK,GREEN)
Applicant
Spi Gloves Sdn. Bhd.
5, Persiaran Greentown 8
Greentown Business Center
Ipoh 30450,  MY
Applicant Contact CHOOI FONG CHUN
Correspondent
Spi Gloves Sdn. Bhd.
5, Persiaran Greentown 8
Greentown Business Center
Ipoh 30450,  MY
Correspondent Contact CHOOI FONG CHUN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received03/02/2005
Decision Date 03/16/2005
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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