POWDER FREE NITRILE EXAMINATION GLOVE


Device Classification Name

polymer patient examination glove

510(k) Number K011012
Device Name POWDER FREE NITRILE EXAMINATION GLOVE
Original Applicant
CONTRACT LATEX DIPPERS SDN BHD
lot 5b, 7a & 8a fasa 2
kawasan miel
batang kali, selangor, 

MY

44300

Original Contact vinayagan ramalingam
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 04/04/2001
Decision Date 05/01/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No