RUBBERCARE POWDER FREE NITRILE EXAMINATION GLOVE


Device Classification Name

polymer patient examination glove

510(k) Number K103661
Device Name RUBBERCARE POWDER FREE NITRILE EXAMINATION GLOVE
Applicant
RUBBERCARE PROTECTION PRODUCTS SDN BHD
off jalan senawang empat
senawang industrial estate
seremban negeri sembilan, 

MY

70450

Applicant Contact lim kwee shyan
Correspondent
RUBBERCARE PROTECTION PRODUCTS SDN BHD
off jalan senawang empat
senawang industrial estate
seremban negeri sembilan, 

MY

70450

Correspodent Contact lim kwee shyan
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 12/16/2010
Decision Date 03/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No