STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING


Device Classification Name

surgeon’s gloves

510(k) Number K111015
Device Name STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING
Applicant
CARDINAL HEALTH, INC.
1430 waukegan road
mcgaw park, 
IL 
60085

Applicant Contact tatyana bogdan
Regulation Number 878.4460
Classification Product Code
KGO  
Date Received 04/11/2011
Decision Date 05/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No