POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE


Device Classification Name

latex patient examination glove

510(k) Number K081040
Device Name POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
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 04/11/2008
Decision Date 05/20/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No