LANO-E


Device Classification Name

latex patient examination glove

510(k) Number K111604
Device Name LANO-E
Applicant
UG GLOBAL RESOURCES SDN BHD
1565 sunflower ave.
costa mesa, 
CA 
92626

Applicant Contact kenneth stanton
Correspondent
UG GLOBAL RESOURCES SDN BHD
1565 sunflower ave.
costa mesa, 
CA 
92626

Correspodent Contact kenneth stanton
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 06/08/2011
Decision Date 06/08/2012
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