NITRI GRIP POWDERED NITRILE EXAMINATION GLOVES


Device Classification Name

polymer patient examination glove

510(k) Number K022572
Device Name NITRI GRIP POWDERED NITRILE EXAMINATION GLOVES
Original Applicant
AR ALLIANCE HEALTHCARE SDN. BHD.
8, lorong ind. 11, kawasan
perindustrian bukit panchor,
nibong tebal, pulau pinang, 

MY

14300

Original Contact chua c chuan
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 08/02/2002
Decision Date 11/08/2002
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