BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM


Device Classification Name

patient examination glove, specialty

510(k) Number K121926
Device Name BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM
Applicant
NORTHSTAR HEALTHCARE HOLDINGS
hamilton house, 10 queen st
hamilton, bermuda, 

IE

hm11

Applicant Contact wesley toavs
Regulation Number 880.6250
Classification Product Code
LZC  
Date Received 07/02/2012
Decision Date 09/20/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No