POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINES 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACE


Device Classification Name

latex patient examination glove

510(k) Number K030583
Device Name POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINES 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACE
Applicant
SHEN WEI (USA), INC.
2845 whipple rd.
union city, 
CA 
94587

Applicant Contact belle l chou
Correspondent
SHEN WEI (USA), INC.
2845 whipple rd.
union city, 
CA 
94587

Correspodent Contact belle l chou
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 02/24/2003
Decision Date 11/10/2003
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