POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMS, GREEN COLOR


Device Classification Name

latex patient examination glove

510(k) Number K022220
Device Name POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMS, GREEN COLOR
Original Applicant
SHEN WEI (USA), INC.
2845 whipple rd.
union city, 
CA 
94587

Original Contact belle l chou
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 07/09/2002
Decision Date 09/23/2002
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