Permark Sdn. Bhd.
MalaysiaFDA applicant, unverified
- Devices
- 1
What Permark Sdn. Bhd. makes
Permark Sdn. Bhd. manufactures latex patient examination gloves designed for clinical use, providing a barrier between healthcare providers and patients during medical examinations.
These gloves are classified as Class I medical 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 K892620
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Permark Sdn. Bhd. have in the registry?
The registry currently lists 1 device for Permark Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Permark Sdn. Bhd.'s devices?
Among its 1 most recently registered device, Permark Sdn. Bhd. has devices listed in FDA 510(k) (1 device).
What risk classes do Permark Sdn. Bhd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Permark Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Permark Sdn. Bhd. in the registry?
The most recently registered devices listed for Permark Sdn. Bhd. include PATIENT EXAMINATION GLOVES (LATEX).