Penflex Corp. Sdn. Bhd.
MalaysiaFDA applicant, unverified
- Devices
- 1
What Penflex Corp. Sdn. Bhd. makes
Penflex Corp. Sdn. Bhd. manufactures latex patient examination gloves, designed for single-use clinical 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 United States.
Catalogue
Patient Examination Gloves (Latex) Ref K891655
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Penflex Corp. Sdn. Bhd. have in the registry?
The registry currently lists 1 device for Penflex Corp. Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Penflex Corp. Sdn. Bhd.'s devices?
Among its 1 most recently registered device, Penflex Corp. Sdn. Bhd. has devices listed in FDA 510(k) (1 device).
What risk classes do Penflex Corp. Sdn. Bhd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Penflex Corp. Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Penflex Corp. Sdn. Bhd. in the registry?
The most recently registered devices listed for Penflex Corp. Sdn. Bhd. include PATIENT EXAMINATION GLOVES (LATEX).