POWDER-FREE RADIATION ATTENUATING NEOPRENE SURGICAL GLOVE (BLACK)


Device Classification Name

surgeon’s gloves

510(k) Number K022873
Device Name POWDER-FREE RADIATION ATTENUATING NEOPRENE SURGICAL GLOVE (BLACK)
Original Applicant
INTERNATIONAL BIOMEDICAL, INC.
8508 cross park dr.
austin, 
TX 
78754

Original Contact amy r pieper
Regulation Number 878.4460
Classification Product Code
KGO  
Date Received 08/29/2002
Decision Date 03/21/2003
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