STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING


Device Classification Name

surgeon’s gloves

510(k) Number K111868
Device Name STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING
Applicant
CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES
1430 waukegan rd.
mcgaw park, 
IL 
60085

Applicant Contact tatyana bogdan
Correspondent
CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES
1430 waukegan rd.
mcgaw park, 
IL 
60085

Correspodent Contact tatyana bogdan
Regulation Number 878.4460
Classification Product Code
KGO  
Date Received 07/01/2011
Decision Date 09/21/2011
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