Pt. Smartglove Indonesia
IndonesiaFDA applicant, unverified
- Devices
- 12
What Pt. Smartglove Indonesia makes
The company manufactures single-use examination gloves for medical and healthcare settings, including powdered and powder-free varieties made from nitrile, latex, and polychloroprene materials. Products include standard examination gloves, chemotherapy-compatible gloves, and flavored options. Some gloves feature polymer coatings or reduced protein content for specific clinical needs.
All listed devices fall under Class I regulatory classification in the U.S. and are recorded in the FDA 510(k) Premarket Notification Database. The manufacturer is based in the United States.
Catalogue
Search and filter all 12 devicesFrequently asked questions
How many devices does Pt. Smartglove Indonesia have in the registry?
The registry currently lists 12 devices for Pt. Smartglove Indonesia. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pt. Smartglove Indonesia's devices?
Among its 12 most recently registered devices, Pt. Smartglove Indonesia has devices listed in FDA 510(k) (12 devices).
What risk classes do Pt. Smartglove Indonesia's devices fall under?
Among its 12 most recently registered devices, the classes recorded for Pt. Smartglove Indonesia's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Pt. Smartglove Indonesia in the registry?
The most recently registered devices listed for Pt. Smartglove Indonesia include POWDER FREE NITRILE EXAMINATION GLOVES, BLACK, MULTIPLE NITRILE EXAMINATION GLOVES (POWDERED), POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR and POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE).