STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG


Device Classification Name

surgeon’s gloves

510(k) Number K110272
Device Name STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG
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  
Subsequent Product Code
LZC  
Date Received 01/31/2011
Decision Date 06/08/2011
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