NON-STERILE, POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)


Device Classification Name

latex patient examination glove

510(k) Number K112005
Device Name NON-STERILE, POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Applicant
UG HEALTHCARE (USA), INC.
1656 sunflower ave.
costa mesa, 
CA 
92626

Applicant Contact ken stanton
Correspondent
UG HEALTHCARE (USA), INC.
1656 sunflower ave.
costa mesa, 
CA 
92626

Correspodent Contact ken stanton
Regulation Number 880.6250
Classification Product Code
LYY  
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