Speedtech Sdn Bhd
MalaysiaFDA applicant, unverified
- Devices
- 1
What Speedtech Sdn Bhd makes
Speedtech 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 510(k) clearance. The company is based in the United States.
Catalogue
Patient Examination Gloves (Latex) Ref K892031
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Speedtech Sdn Bhd have in the registry?
The registry currently lists 1 device for Speedtech Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Speedtech Sdn Bhd's devices?
Among its 1 most recently registered device, Speedtech Sdn Bhd has devices listed in FDA 510(k) (1 device).
What risk classes do Speedtech Sdn Bhd's devices fall under?
Among its 1 most recently registered device, the classes recorded for Speedtech Sdn Bhd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Speedtech Sdn Bhd in the registry?
The most recently registered devices listed for Speedtech Sdn Bhd include PATIENT EXAMINATION GLOVES (LATEX).