Prowell Industries Sdn. Bhd.
MalaysiaFDA applicant, unverified
- Devices
- 1
What Prowell Industries Sdn. Bhd. makes
Prowell Industries Sdn. Bhd. manufactures latex patient examination gloves, designed for clinical use during medical procedures and examinations.
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 K891933
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Prowell Industries Sdn. Bhd. have in the registry?
The registry currently lists 1 device for Prowell Industries Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Prowell Industries Sdn. Bhd.'s devices?
Among its 1 most recently registered device, Prowell Industries Sdn. Bhd. has devices listed in FDA 510(k) (1 device).
What risk classes do Prowell Industries Sdn. Bhd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Prowell Industries Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Prowell Industries Sdn. Bhd. in the registry?
The most recently registered devices listed for Prowell Industries Sdn. Bhd. include PATIENT EXAMINATION GLOVES (LATEX).