FDA.reportPublic FDA data

510(k) K213076

Device
AspenMed+
Applicant
Aspen Glove Sdn. Bhd.
510(k) number
K213076
Product code
LZC
Decision
Substantially Equivalent (SESE)
Decision date
2021-12-20
Date received
2021-09-23
Regulation
880.6250
Classification name
Medical Glove, Specialty
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Iskandar Basha Bin Abdul Kadir
Address
Aspen House, 300, Jln Macalister Georgetown MY 10450 10450

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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