DERMAGRIP AND MULTIPLE POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NON-STERILE


Device Classification Name

polymer patient examination glove

510(k) Number K021396
Device Name DERMAGRIP AND MULTIPLE POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NON-STERILE
Original Applicant
WRP SPECIALTY PRODUCTS SDN. BHD.
lot11 jalan2 perusahaan bandar
kawasan baru salak tinggi
sepang, selangor, 

MY

43900

Original Contact v. nadarajan
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 05/02/2002
Decision Date 05/16/2002
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