Fabella Industries Sdn Bhd
MalaysiaFDA 510(k) applicant, unverified
- Devices
- 1
What Fabella Industries Sdn Bhd makes
Fabella Industries Sdn Bhd manufactures latex patient examination gloves, designed for clinical use during medical procedures to maintain sterility and reduce contamination risk.
These gloves are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway in the United States. The company is based in the US.
Catalogue
Patient Examination Gloves (Latex) Ref K892556
510(k) 510(k)
Frequently asked questions
How many devices does Fabella Industries Sdn Bhd have in the registry?
The registry currently lists 1 device for Fabella Industries Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fabella Industries Sdn Bhd's devices?
Among its 1 most recently registered device, Fabella Industries Sdn Bhd has devices listed in FDA 510(k) (1 device).
What risk classes do Fabella Industries Sdn Bhd's devices fall under?
Among its 1 most recently registered device, the classes recorded for Fabella Industries Sdn Bhd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Fabella Industries Sdn Bhd in the registry?
The most recently registered devices listed for Fabella Industries Sdn Bhd include PATIENT EXAMINATION GLOVES (LATEX).