Pt Nusa Dipa Perdana
Country not established
- Devices
- 1
What Pt Nusa Dipa Perdana makes
Pt Nusa Dipa Perdana manufactures latex patient examination gloves, designed for sterile or non-sterile use during clinical examinations and procedures. These gloves are intended to provide barrier protection against contamination while maintaining tactile sensitivity for healthcare providers.
The company’s product portfolio is regulated under FDA Class I medical devices, requiring compliance with 510(k) clearance for market authorisation in the United States. The manufacturer operates from the US, adhering to applicable domestic regulatory standards for device safety and performance.
Catalogue
Protex Patient Examination Gloves (Latex) Ref K892115
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pt Nusa Dipa Perdana have in the registry?
The registry currently lists 1 device for Pt Nusa Dipa Perdana. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pt Nusa Dipa Perdana's devices?
Among its 1 most recently registered device, Pt Nusa Dipa Perdana has devices listed in FDA 510(k) (1 device).
What risk classes do Pt Nusa Dipa Perdana's devices fall under?
Among its 1 most recently registered device, the classes recorded for Pt Nusa Dipa Perdana's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Pt Nusa Dipa Perdana in the registry?
The most recently registered devices listed for Pt Nusa Dipa Perdana include PROTEX PATIENT EXAMINATION GLOVES (LATEX).