ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA


Device Classification Name

surgeon’s gloves

510(k) Number K103714
Device Name ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA
Applicant
ANSELL HEALTHCARE PRODUCTS, LLC
555 zang street, suite 100
lakewood, 
CO 
80228

Applicant Contact mary l armstrong
Correspondent
ANSELL HEALTHCARE PRODUCTS, LLC
555 zang street, suite 100
lakewood, 
CO 
80228

Correspodent Contact mary l armstrong
Regulation Number 878.4460
Classification Product Code
KGO  
Subsequent Product Code
LZC  
Date Received 12/21/2010
Decision Date 07/07/2011
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