NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS


Device Classification Name

polymer patient examination glove

510(k) Number K111134
Device Name NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Applicant
SIEM AEMPEMED CORP., LTD
13900 49th street
clearwater, 
FL 
33762

Applicant Contact william e harris, iii
Correspondent
SIEM AEMPEMED CORP., LTD
13900 49th street
clearwater, 
FL 
33762

Correspodent Contact william e harris, iii
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 04/22/2011
Decision Date 01/26/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No