CLEANTEXX POWDERFREE BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVES, BLUE COLOUR


Device Classification Name

polymer patient examination glove

510(k) Number K022102
Device Name CLEANTEXX POWDERFREE BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVES, BLUE COLOUR
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 06/28/2002
Decision Date 08/22/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No