NON STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, POLYMER COATING WITH CHEMOTHERAPY CLAIM


Device Classification Name

polymer patient examination glove

510(k) Number K080520
Device Name NON STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, POLYMER COATING WITH CHEMOTHERAPY CLAIM
Applicant
SIAM SEMPERMED CORP. LTD.
13900 49th street north
clearwater, 
FL 
33762

Applicant Contact william e harris
Correspondent
SIAM SEMPERMED CORP. LTD.
13900 49th street north
clearwater, 
FL 
33762

Correspodent Contact william e harris
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 02/25/2008
Decision Date 04/30/2008
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