HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES – BLUE COLOR


information about

Device Classification Name

latex patient examination glove

510(k) Number K000952
Device Name HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES – BLUE COLOR
Original Applicant
PAMITEX INDUSTRIES SDN BHD
2 1/2 miles, jalan rasah
seremban, nageri sembilan
darul khusus, 

MY

70300

Original Contact said awang
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 03/24/2000
Decision Date 06/30/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No