MICRO-TOUCH NITRAFREE


Device Classification Name

polymer patient examination glove

510(k) Number K080536
Device Name MICRO-TOUCH NITRAFREE
Applicant
ANSELL HEALTHCARE PRODUCTS LLC
1635 industrial rd.
dothan, 
AL 
36303

Applicant Contact lon d mciivain
Correspondent
ANSELL HEALTHCARE PRODUCTS LLC
1635 industrial rd.
dothan, 
AL 
36303

Correspodent Contact lon d mciivain
Regulation Number 880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received 02/27/2008
Decision Date 06/19/2008
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