CHIENMAX VIETNAM CO. LTD POWDER FREE BLUE NITRILE EXAMINATION GLOVE


Device Classification Name

polymer patient examination glove

510(k) Number K103675
Device Name CHIENMAX VIETNAM CO. LTD POWDER FREE BLUE NITRILE EXAMINATION GLOVE
Applicant
CHIENMAX VIETNAM CO. LTD
55 northern blvd., suite 200
great neck, 
NY 
11021

Applicant Contact jigar shah
Correspondent
CHIENMAX VIETNAM CO. LTD
55 northern blvd., suite 200
great neck, 
NY 
11021

Correspodent Contact jigar shah
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 12/16/2010
Decision Date 10/03/2011
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