SYNTHETICARE POWDERED VINYL EXAMINATION GLOVES


Device Classification Name

vinyl patient examination glove

510(k) Number K030484
Device Name SYNTHETICARE POWDERED 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