P.T. Saptindo Surgica
Country not established
- Devices
- 3
What P.T. Saptindo Surgica makes
P.T. Saptindo Surgica manufactures sterile, powder-free surgical gloves, including latex and synthetic variants with polymer coatings. Their product line includes gloves designed for surgeons, such as the Medi Plus Surgeon’s Gloves, intended for use in medical procedures requiring barrier protection.
These devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The manufacturer operates from the United States, adhering to applicable regulatory requirements for sterile surgical gloves.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Medi Plus Surgeon's Gloves Ref K945363
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does P.T. Saptindo Surgica have in the registry?
The registry currently lists 3 devices for P.T. Saptindo Surgica. Devices recorded under merged duplicate company entries are counted once.
Which registries list P.T. Saptindo Surgica's devices?
Among its 3 most recently registered devices, P.T. Saptindo Surgica has devices listed in FDA 510(k) (3 devices).
What risk classes do P.T. Saptindo Surgica's devices fall under?
Among its 3 most recently registered devices, the classes recorded for P.T. Saptindo Surgica's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from P.T. Saptindo Surgica in the registry?
The most recently registered devices listed for P.T. Saptindo Surgica include STERILE POWDER FREE LATEX SURGICAL GLOVE WITH POLYMER COATING, STERILE POWDER FREE SYNTHETIC SURGICAL GLOVE WITH POLYMER COATING and MEDI PLUS SURGEON'S GLOVES.