BIOGEL (R) INDICATOR (R) UNDERGLOVE


Device Classification Name

surgeon’s gloves

510(k) Number K111413
Device Name BIOGEL (R) INDICATOR (R) UNDERGLOVE
Applicant
MOLNLYCKE HEALTHCARE, US LLC
5550 peachtree parkway
suite 500
norcross, 
GA 
30092

Applicant Contact angela l bunn
Correspondent
MOLNLYCKE HEALTHCARE, US LLC
5550 peachtree parkway
suite 500
norcross, 
GA 
30092

Correspodent Contact angela l bunn
Regulation Number 878.4460
Classification Product Code
KGO  
Date Received 05/20/2011
Decision Date 01/30/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No