MEDTEXX BLUE COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES


Device Classification Name

polymer patient examination glove

510(k) Number K022548
Device Name MEDTEXX BLUE COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES
Original Applicant
LATEXX MANUFACTURING SDN.BHD.
216 charles st.
hackensack, 
NJ 
07601

Original Contact law siau woei
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 08/01/2002
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