LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING

Device Classification Name

patient examination glove, specialty

510(k) Number K033789
Device Name LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING
Applicant
Cardinal Health
1500 waukegan rd. bldg. wm
mcgaw park, 
IL 
60085

Applicant Contact erica sethi
Correspondent
Cardinal Health
1500 waukegan rd. bldg. wm
mcgaw park, 
IL 
60085

Correspodent Contact erica sethi
Regulation Number 880.6250
Classification Product Code
LZC  
Date Received 12/04/2003
Decision Date 05/07/2004
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