Promedica Sdn. Bhd.
MalaysiaFDA applicant, unverified
- Devices
- 1
What Promedica Sdn. Bhd. makes
Promedica Sdn. Bhd. manufactures latex patient examination gloves designed for clinical use, providing barrier protection during medical procedures.
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 United States.
Catalogue
Patient Examination Gloves (Latex) Ref K891499
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Promedica Sdn. Bhd. have in the registry?
The registry currently lists 1 device for Promedica Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Promedica Sdn. Bhd.'s devices?
Among its 1 most recently registered device, Promedica Sdn. Bhd. has devices listed in FDA 510(k) (1 device).
What risk classes do Promedica Sdn. Bhd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Promedica Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Promedica Sdn. Bhd. in the registry?
The most recently registered devices listed for Promedica Sdn. Bhd. include PATIENT EXAMINATION GLOVES (LATEX).