DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U


Device Classification Name

surgeon’s gloves

510(k) Number K111139
Device Name DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U
Applicant
ANSELL HEALTHCARE PRODUCTS, INC.
555 zang street
suite 100
lakewood, 
CO 
80228

Applicant Contact neil burris
Correspondent
ANSELL HEALTHCARE PRODUCTS, INC.
555 zang street
suite 100
lakewood, 
CO 
80228

Correspodent Contact neil burris
Regulation Number 878.4460
Classification Product Code
KGO  
Subsequent Product Code
LZC  
Date Received 04/22/2011
Decision Date 09/02/2011
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