MEDTEXX GREEN COLOUR POWDERED NITRILE RUBBER EXAMINATION GLOVES


Device Classification Name

polymer patient examination glove

510(k) Number K022347
Device Name MEDTEXX GREEN COLOUR POWDERED NITRILE RUBBER EXAMINATION GLOVES
Original Applicant
LATEXX MANUFACTURING SDN.BHD.
pt. 5054, p.o. box 9
kamunting industrial estate
taiping, perak, 

MY

34600

Original Contact teoh choh shee
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 07/19/2002
Decision Date 08/15/2002
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