Pt. Sarana Indoprotex
Country not established
- Devices
- 4
What Pt. Sarana Indoprotex makes
Pt. Sarana Indoprotex manufactures powder-free and low-protein latex patient examination gloves, including standard exam gloves and a product line called ANDAL. These items are designed for medical and clinical use to reduce allergic reactions and contamination risks during patient examinations.
The company’s products are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. The portfolio is registered in the United States, where the manufacturer is based.
Catalogue
Powder-Free Exam Gloves Ref K970773
Regimes: 510(k) Registry: 510(k)Andal Ref K950823
Regimes: 510(k) Registry: 510(k)Patient Examination Glovews Ref K913531
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pt. Sarana Indoprotex have in the registry?
The registry currently lists 4 devices for Pt. Sarana Indoprotex. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pt. Sarana Indoprotex's devices?
Among its 4 most recently registered devices, Pt. Sarana Indoprotex has devices listed in FDA 510(k) (4 devices).
What risk classes do Pt. Sarana Indoprotex's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Pt. Sarana Indoprotex's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Pt. Sarana Indoprotex in the registry?
The most recently registered devices listed for Pt. Sarana Indoprotex include POWDER-FREE EXAM GLOVES, ANDAL, PATIENT EXAMINATION GLOVEWS and LOW PROTEIN LATEX PATIENT EXAMINATION GLOVES (POWDER-FREE).