Pantai Utama Sdn. Bhd.
MalaysiaFDA applicant, unverified
- Devices
- 2
What Pantai Utama Sdn. Bhd. makes
Pantai Utama Sdn. Bhd. manufactures latex examination gloves, including both powdered and powderfree variants.
The company's products are classified as Class I medical devices and are listed in the FDA 510(k) registry. Pantai Utama Sdn. Bhd. is based in the US.
Catalogue
Prepowdered Latex Examination Gloves Ref K955888
Regimes: 510(k) Registry: 510(k)Powderfree Latex Examination Gloves Ref K955889
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pantai Utama Sdn. Bhd. have in the registry?
The registry currently lists 2 devices for Pantai Utama Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pantai Utama Sdn. Bhd.'s devices?
Among its 2 most recently registered devices, Pantai Utama Sdn. Bhd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Pantai Utama Sdn. Bhd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Pantai Utama Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Pantai Utama Sdn. Bhd. in the registry?
The most recently registered devices listed for Pantai Utama Sdn. Bhd. include PREPOWDERED LATEX EXAMINATION GLOVES and POWDERFREE LATEX EXAMINATION GLOVES.