NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREE


Device Classification Name

surgeon’s gloves

510(k) Number K110698
Device Name NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREE
Applicant
TERANG NUSA SDN BHD
1, jalan 8,
pengkalan chepa 2 ind. zone
kota bharu, kelantan, 

MY

16100

Applicant Contact robert hill
Correspondent
TERANG NUSA SDN BHD
1, jalan 8,
pengkalan chepa 2 ind. zone
kota bharu, kelantan, 

MY

16100

Correspodent Contact robert hill
Regulation Number 878.4460
Classification Product Code
KGO  
Date Received 02/17/2011
Decision Date 12/07/2011
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