Pt. Indolex Karya Prakarsa
IndonesiaFDA applicant, unverified
- Devices
- 1
What Pt. Indolex Karya Prakarsa makes
Pt. Indolex Karya Prakarsa manufactures latex patient examination gloves, designed for single-use medical procedures requiring barrier protection.
These gloves 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 (Latex) Ref K892610
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pt. Indolex Karya Prakarsa have in the registry?
The registry currently lists 1 device for Pt. Indolex Karya Prakarsa. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pt. Indolex Karya Prakarsa's devices?
Among its 1 most recently registered device, Pt. Indolex Karya Prakarsa has devices listed in FDA 510(k) (1 device).
What risk classes do Pt. Indolex Karya Prakarsa's devices fall under?
Among its 1 most recently registered device, the classes recorded for Pt. Indolex Karya Prakarsa's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Pt. Indolex Karya Prakarsa in the registry?
The most recently registered devices listed for Pt. Indolex Karya Prakarsa include PATIENT EXAMINATION GLOVES (LATEX).