BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN


Device Classification Name

latex patient examination glove

510(k) Number K991750
Device Name BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN
Applicant
BRIGHTSWAY HOLDINGS SDN BHD
batu belah
klang selangor darul ehsan, 

MY

42100

Applicant Contact g. baskaran
Correspondent
BRIGHTSWAY HOLDINGS SDN BHD
batu belah
klang selangor darul ehsan, 

MY

42100

Correspodent Contact g. baskaran
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 05/24/1999
Decision Date 06/23/1999
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