BRIGHTWAY BRAND NITRILE SURGICAL GLOVES – STERILE (POWDERED)


Device Classification Name

surgeon’s gloves

510(k) Number K991940
Device Name BRIGHTWAY BRAND NITRILE SURGICAL GLOVES – STERILE (POWDERED)
Applicant
BRIGHTWAY HOLDINGS SDN. BHD.
lot 1559, jalan istimewa,
batu belah
klang, selangor, 

MY

42100

Applicant Contact g. baskaran
Correspondent
BRIGHTWAY HOLDINGS SDN. BHD.
lot 1559, jalan istimewa,
batu belah
klang, selangor, 

MY

42100

Correspodent Contact g. baskaran
Regulation Number 878.4460
Classification Product Code
KGO  
Date Received 06/09/1999
Decision Date 07/12/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No