P.T. Indo Rama Synthetics
ID Last updated 22 Oct 2026
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- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Patient Examination Gloves (Latex) Ref K892789
What P.T. Indo Rama Synthetics makes
The company manufactures latex patient examination gloves, designed for single-use medical procedures to ensure sterility and barrier protection during clinical examinations.
These gloves are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer operates from the United States.
Frequently asked questions
What types of medical devices does P.T. Indo Rama Synthetics manufacture?
P.T. Indo Rama Synthetics manufactures latex patient examination gloves, which are intended for single-use medical procedures. These gloves are designed to provide sterility and barrier protection during clinical examinations, ensuring hygiene and safety for both patients and healthcare providers.
Where is P.T. Indo Rama Synthetics based?
The company operates from the United States, where it develops and produces its medical devices.
How are the company’s devices classified under FDA regulations?
The company’s latex patient examination gloves fall under Class I medical device classification according to FDA regulations. This classification applies to devices posing minimal risk, typically those with well-established safety and performance profiles, such as single-use gloves.
Are the company’s devices listed in any regulatory registries?
Yes, the company’s latex patient examination gloves are listed via the FDA’s 510(k) pathway. This pathway is used for devices that are substantially equivalent to legally marketed predicate devices, ensuring compliance with regulatory requirements before commercial distribution.
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