PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES


Device Classification Name

surgeon’s gloves

510(k) Number K111878
Device Name PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES
Applicant
CARDINAL HEALTH, INC.
1430 waukegan road
mcgaw park, 
IL 
60085

Applicant Contact tatyana bogdan
Correspondent
CARDINAL HEALTH, INC.
1430 waukegan road
mcgaw park, 
IL 
60085

Correspodent Contact tatyana bogdan
Regulation Number 878.4460
Classification Product Code
KGO  
Date Received 07/01/2011
Decision Date 09/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No