510(k) K061551

Device
POWDER FREE LATEX EXAMINATION GLOVES, NATURAL OR BLUE COLOUR AND WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS)
Applicant
Medipure Corporation (M) Sdn. Bhd.
510(k) number
K061551
Product code
LYY
Decision
Substantially Equivalent (SESE)
Decision date
2006-08-24
Date received
2006-06-05
Regulation
880.6250
Classification name
Latex Patient Examination Glove
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
TERENCE LIM SIN KOOI
Address
Lot 12 Medan Tasek Tasek Industrail Estate Ipoh, Perak MY 31400 31400

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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