FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES


Device Classification Name

polymer patient examination glove

510(k) Number K022671
Device Name FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES
Original Applicant
HARTALEGA SDN BHD
2301 robb dr.
reno, 
NV 
89523

Original Contact tito aldape
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 08/12/2002
Decision Date 11/18/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No