Pt. Herlin Dharma Persada
IndonesiaFDA applicant, unverified
- Devices
- 1
What Pt. Herlin Dharma Persada makes
Pt. Herlin Dharma Persada manufactures TopClean Patient Examination Gloves, a single-use barrier protection product designed for clinical examinations and procedures to reduce contamination risk.
The company’s portfolio is regulated under FDA Class I devices, with the TopClean Patient Examination Gloves listed in the FDA 510(k) registry. The manufacturer is based in the United States.
Catalogue
Topclean Patient Examination Gloves Ref K893158
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pt. Herlin Dharma Persada have in the registry?
The registry currently lists 1 device for Pt. Herlin Dharma Persada. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pt. Herlin Dharma Persada's devices?
Among its 1 most recently registered device, Pt. Herlin Dharma Persada has devices listed in FDA 510(k) (1 device).
What risk classes do Pt. Herlin Dharma Persada's devices fall under?
Among its 1 most recently registered device, the classes recorded for Pt. Herlin Dharma Persada's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Pt. Herlin Dharma Persada in the registry?
The most recently registered devices listed for Pt. Herlin Dharma Persada include TOPCLEAN PATIENT EXAMINATION GLOVES.