Pt. Mandiri Inti Buana
IndonesiaFDA applicant, unverified
- Devices
- 4
What Pt. Mandiri Inti Buana makes
The company manufactures single-use examination gloves for healthcare settings, including powder-free latex, powder-free nitrile, and polymer-coated latex varieties. These gloves are intended for non-sterile medical procedures and are designed to provide barrier protection during patient examinations or procedures.
The portfolio is classified under FDA’s Class I medical devices and is listed via the 510(k) pathway. The manufacturer operates from the United States and adheres to regulatory requirements for non-sterile examination gloves.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- 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. Mandiri Inti Buana have in the registry?
The registry currently lists 4 devices for Pt. Mandiri Inti Buana. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pt. Mandiri Inti Buana's devices?
Among its 4 most recently registered devices, Pt. Mandiri Inti Buana has devices listed in FDA 510(k) (4 devices).
What risk classes do Pt. Mandiri Inti Buana's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Pt. Mandiri Inti Buana's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Pt. Mandiri Inti Buana in the registry?
The most recently registered devices listed for Pt. Mandiri Inti Buana include FLEXISKIN POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE, FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERILE, FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE and FLEXISKIN LATEX EXAMINATION GLOVES, POWDERED, NON STERILE.