ALATECH POWDERED LATEX PATIENT EXAMINATION GLOVE


Device Classification Name

latex patient examination glove

510(k) Number K080606
Device Name ALATECH POWDERED LATEX PATIENT EXAMINATION GLOVE
Applicant
ALATECH HEALTHCARE, LLC.
1600 state docks rd.
eufaula, 
AL 
36027

Applicant Contact neil anderson
Correspondent
ALATECH HEALTHCARE, LLC.
1600 state docks rd.
eufaula, 
AL 
36027

Correspodent Contact neil anderson
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 03/04/2008
Decision Date 08/07/2008
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