Integrasia Sdn Bhd
MalaysiaFDA applicant, unverified
- Devices
- 1
What Integrasia Sdn Bhd makes
Integrasia Sdn Bhd manufactures latex patient examination gloves, designed for single-use medical procedures to maintain hygiene and reduce infection risk during clinical examinations.
These gloves are classified as Class I devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the US.
Catalogue
Patient Examination Gloves (Latex) Ref K891832
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Integrasia Sdn Bhd have in the registry?
The registry currently lists 1 device for Integrasia Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Integrasia Sdn Bhd's devices?
Among its 1 most recently registered device, Integrasia Sdn Bhd has devices listed in FDA 510(k) (1 device).
What risk classes do Integrasia Sdn Bhd's devices fall under?
Among its 1 most recently registered device, the classes recorded for Integrasia Sdn Bhd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Integrasia Sdn Bhd in the registry?
The most recently registered devices listed for Integrasia Sdn Bhd include PATIENT EXAMINATION GLOVES (LATEX).