Pt Mahakarya Inti Buana
IndonesiaFDA applicant, unverified
- Devices
- 9
What Pt Mahakarya Inti Buana makes
The company manufactures non-sterile examination gloves, including powdered and powder-free latex variants, nitrile gloves in multiple colors, and polymer-coated latex gloves. Products are categorized under high-risk and standard latex formulations, as well as powdered nitrile options.
These devices are classified as Class I under FDA regulations and are listed via 510(k) clearance. The manufacturer operates from the United States.
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)
Senstouch Nitrile Examination Gloves, Powder Free, Non Sterile (Green, Orange, Violet And White) Ref K111300
Regimes: 510(k) Registry: 510(k)- 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 Mahakarya Inti Buana have in the registry?
The registry currently lists 9 devices for Pt Mahakarya Inti Buana. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pt Mahakarya Inti Buana's devices?
Among its 9 most recently registered devices, Pt Mahakarya Inti Buana has devices listed in FDA 510(k) (9 devices).
What risk classes do Pt Mahakarya Inti Buana's devices fall under?
Among its 9 most recently registered devices, the classes recorded for Pt Mahakarya Inti Buana's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Pt Mahakarya Inti Buana in the registry?
The most recently registered devices listed for Pt Mahakarya Inti Buana include POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE, BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE, SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE and SENSTOUCH POWDER FREE EXAMINATION GLOVES, NON STERILE.