DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE,TESTED FOR USE W/ CHEMOTHERAPY DRUGS


Device Classification Name

polymer patient examination glove

510(k) Number K110979
Device Name DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE,TESTED FOR USE W/ CHEMOTHERAPY DRUGS
Applicant
ADVANCED MEDICAL PRODUCTS SDN BHD
lot 8961 & 8964, batu 19
jalan bruas
ayer tawar, 

MY

32400

Applicant Contact zahari darus
Correspondent
ADVANCED MEDICAL PRODUCTS SDN BHD
lot 8961 & 8964, batu 19
jalan bruas
ayer tawar, 

MY

32400

Correspodent Contact zahari darus
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 04/07/2011
Decision Date 10/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No