P.T. Gotong Rojong Djaja
Indonesia(FDA 510(k) applicant) Last updated 22 Oct 2026
- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Latex Patient Examination Gloves Ref K897047
What P.T. Gotong Rojong Djaja makes
P.T. Gotong Rojong Djaja manufactures latex patient examination gloves, designed for single-use medical and clinical examinations.
These products are classified as Class I devices under FDA regulations and are listed via the 510(k) pathway. The company operates from the United States.
Frequently asked questions
What types of medical devices does P.T. Gotong Rojong Djaja manufacture?
P.T. Gotong Rojong Djaja specializes in manufacturing latex patient examination gloves, which are intended for single-use medical and clinical examinations. These gloves are designed to provide a barrier during procedures like physical assessments, ensuring hygiene and reducing infection risks.
Where is P.T. Gotong Rojong Djaja based?
The company operates from the United States, where it develops and produces its medical devices. This location allows it to comply with U.S. regulatory standards and supply markets within North America.
How are P.T. Gotong Rojong Djaja’s devices classified under FDA regulations?
The company’s latex patient examination gloves fall under Class I device classification according to FDA regulations. This classification applies to devices posing minimal risk to users, often requiring general controls (such as good manufacturing practices) rather than specialized premarket approval.
Which regulatory registries or databases list P.T. Gotong Rojong Djaja’s devices?
P.T. Gotong Rojong Djaja’s devices are listed in the FDA’s 510(k) registry, a database of Class I and some Class II devices that demonstrate substantial equivalence to legally marketed predicates. This pathway confirms compliance with FDA requirements for device safety and performance.
Information
- Country
- Indonesia