SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES


Device Classification Name

surgeon’s gloves

510(k) Number K023236
Device Name SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES
Original Applicant
MAXXIM MEDICAL
308 church st
honea path, 
SC 
29654

Original Contact roy e moser
Regulation Number 878.4460
Classification Product Code
KGO  
Date Received 09/27/2002
Decision Date 11/12/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No