NON-STERILE, POWDER-FREE BLUE, NITRILE EXAMINATION GLOVES


Device Classification Name

polymer patient examination glove

510(k) Number K112012
Device Name NON-STERILE, POWDER-FREE BLUE, NITRILE EXAMINATION GLOVES
Applicant
UG HEALTHCARE (USA), INC.
1565 sunflower ave.
costa mesa, 
CA 
92626

Applicant Contact ken stanton
Correspondent
UG HEALTHCARE (USA), INC.
1565 sunflower ave.
costa mesa, 
CA 
92626

Correspodent Contact ken stanton
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 07/13/2011
Decision Date 03/21/2012
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