BRIGHTWAY BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (ORANGE)


Device Classification Name

polymer patient examination glove

510(k) Number K022878
Device Name BRIGHTWAY BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (ORANGE)
Original Applicant
BRIGHTWAY HOLDINGS SDN. BHD.
lot 1559, jalan istimewa,
batu belah
klang, selangor, 

MY

42100

Original Contact g. baskaran
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 08/30/2002
Decision Date 09/17/2002
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