SYNTHETICARE POWDER-FREE VINYL EXAMINATION GLOVES


Device Classification Name

vinyl patient examination glove

510(k) Number K030483
Device Name SYNTHETICARE POWDER-FREE VINYL EXAMINATION GLOVES
Applicant
EMERALD MEDICAL, INC.
55 northern blvd., suite 200
great neck, 
NY 
11021

Applicant Contact susan d goldstein-falk
Correspondent
EMERALD MEDICAL, INC.
55 northern blvd., suite 200
great neck, 
NY 
11021

Correspodent Contact susan d goldstein-falk
Regulation Number 880.6250
Classification Product Code
LYZ  
Date Received 02/14/2003
Decision Date 03/06/2003
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