P.T. Latexindo Parama
Indonesia(FDA 510(k) applicant) Last updated 22 Oct 2026
- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Patient Examination Gloves (Latex) Ref K892636
What P.T. Latexindo Parama makes
P.T. Latexindo Parama manufactures latex patient examination gloves, designed for single-use medical procedures and clinical examinations.
These products are classified as Class I devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Frequently asked questions
What types of medical devices does P.T. Latexindo Parama manufacture?
P.T. Latexindo Parama specializes in manufacturing latex patient examination gloves, which are intended for single-use medical procedures and clinical examinations. These gloves are designed to provide a barrier between healthcare providers and patients during examinations or treatments.
Where is P.T. Latexindo Parama based?
The company is based in the United States. This location allows it to comply with domestic regulatory requirements, including those set by the FDA for medical devices.
How are P.T. Latexindo Parama’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 is typically assigned to devices posing minimal risk to patients and users, often involving simple, non-invasive procedures.
Which regulatory registries or databases list P.T. Latexindo Parama’s devices?
P.T. Latexindo Parama’s devices are listed in the FDA’s 510(k) registry. This pathway is used for devices that are substantially equivalent to legally marketed predicates, ensuring compliance with FDA requirements before commercial distribution.
Information
- Country
- Indonesia