Sime Darby USA
Country not established
- Devices
- 2
What Sime Darby USA makes
Sime Darby USA manufactures sterile latex examination gloves and latex patient examination gloves, designed for medical and clinical use to maintain hygiene during procedures.
These products are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. The company operates within the United States.
Catalogue
Sterile Latex Examination Gloves Ref K903447
Regimes: 510(k) Registry: 510(k)Patient Examination Gloves (Latex) Ref K891434
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sime Darby USA have in the registry?
The registry currently lists 2 devices for Sime Darby USA. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sime Darby USA's devices?
Among its 2 most recently registered devices, Sime Darby USA has devices listed in FDA 510(k) (2 devices).
What risk classes do Sime Darby USA's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Sime Darby USA's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Sime Darby USA in the registry?
The most recently registered devices listed for Sime Darby USA include STERILE LATEX EXAMINATION GLOVES and PATIENT EXAMINATION GLOVES (LATEX).