ROMED LATEX SURGICAL GLOVES, POWDERED, STERILE


Device Classification Name

surgeon’s gloves

510(k) Number K023139
Device Name ROMED LATEX SURGICAL GLOVES, POWDERED, STERILE
Original Applicant
VAN OOSTVEEN MEDICAL B.V.
herenweg 269
wilnis, holland, 

NL

3648 ch

Original Contact m.j. van oostveen
Regulation Number 878.4460
Classification Product Code
KGO  
Date Received 09/20/2002
Decision Date 10/22/2003
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