POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, VIOLET COLOR


Device Classification Name

polymer patient examination glove

510(k) Number K024025
Device Name POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, VIOLET COLOR
Original Applicant
KOSSAN LATEX INDUSTRIES (M) SDN. BHD.
1301 defense highway
gambrills, 
MD 
21054

Original Contact james f logan
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 12/06/2002
Decision Date 12/18/2002
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