DURACLEAN WITH LYCRA POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE


Device Classification Name

polymer patient examination glove

510(k) Number K022095
Device Name DURACLEAN WITH LYCRA POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE
Original Applicant
WILSHIRE TECHNOLOGIES
13221 maricotte place
san diego, 
CA 
92130

Original Contact steve reitzler
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 06/27/2002
Decision Date 08/09/2002
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