DERMAGRIP-P POWDER FREE PINK NITRILE EXAMINATION GLOVES, NON-STERILE


Device Classification Name

polymer patient examination glove

510(k) Number K023517
Device Name DERMAGRIP-P POWDER FREE PINK NITRILE EXAMINATION GLOVES, NON-STERILE
Original Applicant
WRP ASIA PACIFIC SDN. BHD.
lot 1, jalan 3,
kawasan perusahaan bandar baru
salak tinggi, sepang selangor, 

MY

43900

Original Contact terence lim
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 10/18/2002
Decision Date 12/02/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No