POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM


Device Classification Name

latex patient examination glove

510(k) Number K030325
Device Name POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM
Original Applicant
PT. SHAMROCK MANUFACTURING CORP.
5445 daniels st.
chino, 
CA 
91710

Original Contact emmy tjoeng
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 01/31/2003
Decision Date 03/28/2003
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