ECLIPSE LATEX POWDER FREE STERILE SURGEON’S GLOVE


Device Classification Name

surgeon’s gloves

510(k) Number K050533
Device Name ECLIPSE LATEX POWDER FREE STERILE SURGEON’S GLOVE
Applicant
REGENT MEDICAL AMERICAS, LLC
3585 engineering dr, ste 250
norcross, 
GA 
30092

Applicant Contact kathleen harris
Correspondent
REGENT MEDICAL AMERICAS, LLC
3585 engineering dr, ste 250
norcross, 
GA 
30092

Correspodent Contact kathleen harris
Regulation Number 878.4460
Classification Product Code
KGO  
Date Received 03/02/2005
Decision Date 04/26/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No