Sama Kejuruteraan Sdn.Bhd.
MalaysiaFDA applicant, unverified
- Devices
- 1
What Sama Kejuruteraan Sdn.Bhd. makes
Sama Kejuruteraan Sdn.Bhd. manufactures powdered latex examination gloves, designed for medical and clinical use to ensure sterility and reduce contamination during examinations or procedures.
These products are classified as Class I devices under regulatory frameworks and are listed in the FDA’s 510(k) registry. The company operates from the United States.
Catalogue
Latex Examination Gloves (Powdered) Ref K984229
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sama Kejuruteraan Sdn.Bhd. have in the registry?
The registry currently lists 1 device for Sama Kejuruteraan Sdn.Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sama Kejuruteraan Sdn.Bhd.'s devices?
Among its 1 most recently registered device, Sama Kejuruteraan Sdn.Bhd. has devices listed in FDA 510(k) (1 device).
What risk classes do Sama Kejuruteraan Sdn.Bhd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Sama Kejuruteraan Sdn.Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Sama Kejuruteraan Sdn.Bhd. in the registry?
The most recently registered devices listed for Sama Kejuruteraan Sdn.Bhd. include LATEX EXAMINATION GLOVES (POWDERED).