POWDERFREE LATEX EXAMINATION GLOVES WITH GRAPE


Device Classification Name

latex patient examination glove

510(k) Number K030560
Device Name POWDERFREE LATEX EXAMINATION GLOVES WITH GRAPE
Applicant
PT. SHAMROCK MANUFACTURING CORP.
5445 daniels st.
chino, 
CA 
91710

Applicant Contact emmy tjoeng
Correspondent
PT. SHAMROCK MANUFACTURING CORP.
5445 daniels st.
chino, 
CA 
91710

Correspodent Contact emmy tjoeng
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 02/21/2003
Decision Date 03/21/2003
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