CLEANTEXX MINT FLAVOUR BLUE COLOUR POWDER-FREE BARRIER PRO COPOLYMER EXAMINATION GLOVES


Device Classification Name

polymer patient examination glove

510(k) Number K022346
Device Name CLEANTEXX MINT FLAVOUR BLUE COLOUR POWDER-FREE BARRIER PRO COPOLYMER 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 10/18/2002
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