POWDER FREE SYNTHETIC NITRILE NEOPRENE EXAMINATION GLOVES, SIZES SMALL,MEDIUM, LARGE, AND X-LARGE


Device Classification Name

polymer patient examination glove

510(k) Number K030386
Device Name POWDER FREE SYNTHETIC NITRILE NEOPRENE EXAMINATION GLOVES, SIZES SMALL,MEDIUM, LARGE, AND X-LARGE
Applicant
SHAMROCK MANUFACTURING COMPANY
5445 daniels st.
chino, 
CA 
91710

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

Correspodent Contact emmy tjoeng
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 02/05/2003
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