Grafik Hersteller Sdn Bhd
Country not established
- Devices
- 2
What Grafik Hersteller Sdn Bhd makes
Grafik Hersteller Sdn Bhd manufactures powder-free and powered surgical gloves designed for medical use, ensuring compliance with hygiene standards in clinical settings.
These products are classified as Class I medical devices and are listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Gh Gloves (Powder Free) Ref K934048
Regimes: 510(k) Registry: 510(k)Gh Gloves (Powered) Ref K934047
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Grafik Hersteller Sdn Bhd have in the registry?
The registry currently lists 2 devices for Grafik Hersteller Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Grafik Hersteller Sdn Bhd's devices?
Among its 2 most recently registered devices, Grafik Hersteller Sdn Bhd has devices listed in FDA 510(k) (2 devices).
What risk classes do Grafik Hersteller Sdn Bhd's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Grafik Hersteller Sdn Bhd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Grafik Hersteller Sdn Bhd in the registry?
The most recently registered devices listed for Grafik Hersteller Sdn Bhd include GH GLOVES (POWDER FREE) and GH GLOVES (POWERED).