POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE


Device Classification Name

latex patient examination glove

510(k) Number K081488
Device Name POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
Applicant
PT. MAJA AGUNG LATEXINDO
5445 daniels st.
chino, 
CA 
91710

Applicant Contact emmy tjoeng
Correspondent
PT. MAJA AGUNG LATEXINDO
5445 daniels st.
chino, 
CA 
91710

Correspodent Contact emmy tjoeng
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 05/28/2008
Decision Date 08/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No