MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES


Device Classification Name

latex patient examination glove

510(k) Number K110250
Device Name MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES
Applicant
TOTAL GLOVES SDN BHD
kamunting industrial estate
kamunting
taiping, perak, 

MY

34600

Applicant Contact ooi loon seng
Correspondent
TOTAL GLOVES SDN BHD
kamunting industrial estate
kamunting
taiping, perak, 

MY

34600

Correspodent Contact ooi loon seng
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 01/28/2011
Decision Date 10/14/2011
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