Qube Medical Product Sdn Bhd
MalaysiaFDA applicant, unverified
- Devices
- 2
What Qube Medical Product Sdn Bhd makes
Qube Medical Product Sdn Bhd manufactures powder-free examination gloves, including latex and nitrile variants. The gloves are designed for medical and clinical use, with specific formulations such as powder-free latex and powder-free blue nitrile.
These products fall under FDA Class I medical devices and are listed via the 510(k) pathway. The company is based in the US.
Catalogue
Powder Free Latex Examination Gloves Ref K123537
Regimes: 510(k) Registry: 510(k)Powder Free Blue Nitrile Examination Glove Ref K153732
Regimes: CE MDD 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Qube Medical Product Sdn Bhd have in the registry?
The registry currently lists 2 devices for Qube Medical Product Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Qube Medical Product Sdn Bhd's devices?
Among its 2 most recently registered devices, Qube Medical Product Sdn Bhd has devices listed in FDA 510(k) (2 devices).
What risk classes do Qube Medical Product Sdn Bhd's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Qube Medical Product Sdn Bhd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Qube Medical Product Sdn Bhd in the registry?
The most recently registered devices listed for Qube Medical Product Sdn Bhd include POWDER FREE LATEX EXAMINATION GLOVES and Powder Free Blue Nitrile Examination Glove.