Pre Lotus Industrial Sdn. Bhd.
MalaysiaFDA applicant, unverified
- Devices
- 1
What Pre Lotus Industrial Sdn. Bhd. makes
Pre Lotus Industrial Sdn. Bhd. manufactures patient examination gloves, designed for single-use medical procedures requiring barrier protection.
These products 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 Ref K894007
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pre Lotus Industrial Sdn. Bhd. have in the registry?
The registry currently lists 1 device for Pre Lotus Industrial Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pre Lotus Industrial Sdn. Bhd.'s devices?
Among its 1 most recently registered device, Pre Lotus Industrial Sdn. Bhd. has devices listed in FDA 510(k) (1 device).
What risk classes do Pre Lotus Industrial Sdn. Bhd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Pre Lotus Industrial Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Pre Lotus Industrial Sdn. Bhd. in the registry?
The most recently registered devices listed for Pre Lotus Industrial Sdn. Bhd. include PATIENT EXAMINATION GLOVES.