Mirano Sdn. Bhd.
MalaysiaFDA applicant, unverified
- Devices
- 1
What Mirano Sdn. Bhd. makes
Mirano Sdn. Bhd. manufactures latex patient examination gloves, designed for single-use medical procedures requiring barrier protection.
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 K892084
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mirano Sdn. Bhd. have in the registry?
The registry currently lists 1 device for Mirano Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mirano Sdn. Bhd.'s devices?
Among its 1 most recently registered device, Mirano Sdn. Bhd. has devices listed in FDA 510(k) (1 device).
What risk classes do Mirano Sdn. Bhd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Mirano Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Mirano Sdn. Bhd. in the registry?
The most recently registered devices listed for Mirano Sdn. Bhd. include PATIENT EXAMINATION GLOVES (LATEX).