Pt. Eka Wira Asia
Country not established
- Devices
- 3
What Pt. Eka Wira Asia makes
The company manufactures nitrile examination gloves in pre-powdered and powder-free variants, available in small, medium, and large sizes for medical and clinical use.
These devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Latex Examination Gloves, Powder Free Ref K941056
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pt. Eka Wira Asia have in the registry?
The registry currently lists 3 devices for Pt. Eka Wira Asia. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pt. Eka Wira Asia's devices?
Among its 3 most recently registered devices, Pt. Eka Wira Asia has devices listed in FDA 510(k) (3 devices).
What risk classes do Pt. Eka Wira Asia's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Pt. Eka Wira Asia's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Pt. Eka Wira Asia in the registry?
The most recently registered devices listed for Pt. Eka Wira Asia include LATEX EXAMINATION GLOVES, POWDER FREE, NITRILE EXAMINATION GLOVES- PRE-POWDERED (SMALL, MEDIUM & LARGE) and NITRILE EXAMNATION GLOVES- POWDERFREE (SMALL, MEDIUM AND LARGE).