NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS


Device Classification Name

polymer patient examination glove

510(k) Number K110921
Device Name NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Applicant
CARDINAL HEALTH, INC.
1430 waukegan road
mcgaw park, 
IL 
60085

Applicant Contact tatyana bogdan
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 04/01/2011
Decision Date 04/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No