BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

Device Classification Name

surgeon’s gloves

510(k) Number K071414
Device Name BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Applicant
MOLNLYCKE HEALTH CARE US, LLC
5550 peachtree parkway
suite 500
norcross, 
GA 
30092

Applicant Contact steven dowdley
Correspondent
MOLNLYCKE HEALTH CARE US, LLC
5550 peachtree parkway
suite 500
norcross, 
GA 
30092

Correspodent Contact steven dowdley
Regulation Number 878.4460
Classification Product Code
KGO  
Date Received 05/21/2007
Decision Date 09/10/2007
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