Aek Rubber Product Sdn. Bhd.
Country not established
- Devices
- 2
What Aek Rubber Product Sdn. Bhd. makes
Aek Rubber Product Sdn. Bhd. manufactures patient examination gloves, including latex-free and latex versions, designed for clinical use during medical procedures.
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 K892279
Regimes: 510(k) Registry: 510(k)Patient Examination Gloves (Latex) Ref K891258
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Aek Rubber Product Sdn. Bhd. have in the registry?
The registry currently lists 2 devices for Aek Rubber Product Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Aek Rubber Product Sdn. Bhd.'s devices?
Among its 2 most recently registered devices, Aek Rubber Product Sdn. Bhd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Aek Rubber Product Sdn. Bhd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Aek Rubber Product Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Aek Rubber Product Sdn. Bhd. in the registry?
The most recently registered devices listed for Aek Rubber Product Sdn. Bhd. include PATIENT EXAMINATION GLOVES and PATIENT EXAMINATION GLOVES (LATEX).