Setia Aircon Sdn. Bhd.
MalaysiaFDA applicant, unverified
- Devices
- 1
What Setia Aircon Sdn. Bhd. makes
Setia Aircon 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 in the FDA 510(k) registry. The company is based in the United States.
Catalogue
Patient Examination Gloves (Latex) Ref K892148
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Setia Aircon Sdn. Bhd. have in the registry?
The registry currently lists 1 device for Setia Aircon Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Setia Aircon Sdn. Bhd.'s devices?
Among its 1 most recently registered device, Setia Aircon Sdn. Bhd. has devices listed in FDA 510(k) (1 device).
What risk classes do Setia Aircon Sdn. Bhd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Setia Aircon Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Setia Aircon Sdn. Bhd. in the registry?
The most recently registered devices listed for Setia Aircon Sdn. Bhd. include PATIENT EXAMINATION GLOVES (LATEX).