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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 K050765
Device Name LANO-E POWDER-FREE NITRILE EXAMINATION GLOVE
Applicant
N.S. UNI-GLOVES SDN. BHD.
2420 CARSON ST. SUITE 125
TORRANCE,  LA 
Applicant Contact KENNETH J STANTON
Correspondent
N.S. UNI-GLOVES SDN. BHD.
2420 CARSON ST. SUITE 125
TORRANCE,  LA 
Correspondent Contact KENNETH J STANTON
Regulation Number880.6250
Classification Product Code
LZA  
Date Received03/24/2005
Decision Date 04/08/2005
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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