STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIES


Device Classification Name

latex patient examination glove

510(k) Number K081464
Device Name STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIES
Applicant
Cardinal Health
1500 waukegan road
mcgaw park, 
IL 
60085

Applicant Contact steve tamsett
Correspondent
Cardinal Health
1500 waukegan road
mcgaw park, 
IL 
60085

Correspodent Contact steve tamsett
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 05/27/2008
Decision Date 08/28/2008
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