Pt. Intan Hevea Industry
IndonesiaFDA applicant, unverified FDA FEI 3002914051
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Pt. Intan Hevea Industry makes
Pt. Intan Hevea Industry manufactures powder-free latex examination gloves designed for patient examinations and skin protection. These gloves are non-sterile and intended for single-use medical procedures.
The company’s products fall under FDA Class I medical devices and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Patient Examination Gloves Ref K894480
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3002914051
- Address
- JL.PULAU IRIAN (KAWASAN INDUSTRY MEDAN), MEDAN Sumatera Utara
Frequently asked questions
How many devices does Pt. Intan Hevea Industry have in the registry?
The registry currently lists 2 devices for Pt. Intan Hevea Industry. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pt. Intan Hevea Industry's devices?
Among its 2 most recently registered devices, Pt. Intan Hevea Industry has devices listed in FDA 510(k) (2 devices).
What risk classes do Pt. Intan Hevea Industry's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Pt. Intan Hevea Industry's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Pt. Intan Hevea Industry in the registry?
The most recently registered devices listed for Pt. Intan Hevea Industry include PATIENT EXAMINATION GLOVES and SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE.