COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL


the company

Device Classification Name

polymer patient examination glove

510(k) Number K002064
Device Name COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL
Original Applicant
WRP ASIA PACIFIC SDN. BHD.
lot 1, jalan 3,
kawasan perusahaan bandar baru
salak tinggi, sepang selangor, 

MY

43900

Original Contact yue wah chow
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 07/07/2000
Decision Date 11/28/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No