Ganda Yakin Sdn Bhd
MalaysiaFDA applicant, unverified
- Devices
- 1
What Ganda Yakin Sdn Bhd makes
Ganda Yakin 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 K891244
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ganda Yakin Sdn Bhd have in the registry?
The registry currently lists 1 device for Ganda Yakin Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ganda Yakin Sdn Bhd's devices?
Among its 1 most recently registered device, Ganda Yakin Sdn Bhd has devices listed in FDA 510(k) (1 device).
What risk classes do Ganda Yakin Sdn Bhd's devices fall under?
Among its 1 most recently registered device, the classes recorded for Ganda Yakin Sdn Bhd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Ganda Yakin Sdn Bhd in the registry?
The most recently registered devices listed for Ganda Yakin Sdn Bhd include PATIENT EXAMINATION GLOVES (LATEX).