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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
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