STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENTAL EXAMINATION GLOVE


Device Classification Name

polymer patient examination glove

510(k) Number K021452
Device Name STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENTAL EXAMINATION GLOVE
Original Applicant
MAXXIM MEDICAL
4750 118th avenue north
clearwater, 
FL 
33762

Original Contact julio gonzalez
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 05/06/2002
Decision Date 08/01/2002
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