MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, PINK


Device Classification Name

polymer patient examination glove

510(k) Number K122465
Device Name MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, PINK
Applicant
INDUSTRIAL CLOTHINGS, LTD.
d 17, seethawaka export
processing zone
auissawella, 

LK

10700

Applicant Contact s.n. hari
Correspondent
INDUSTRIAL CLOTHINGS, LTD.
d 17, seethawaka export
processing zone
auissawella, 

LK

10700

Correspodent Contact s.n. hari
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 08/13/2012
Decision Date 10/16/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No