P.T. Tulip Indah Agung
ID Last updated 22 Oct 2026
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- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Patient Examination Gloves Ref K903703
What P.T. Tulip Indah Agung makes
P.T. Tulip Indah Agung manufactures patient examination gloves, designed for single-use medical procedures requiring sterile barriers between healthcare providers and patients.
These gloves 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. Tulip Indah Agung manufacture?
P.T. Tulip Indah Agung specializes in manufacturing patient examination gloves, which are intended for single-use medical procedures. These gloves serve as sterile barriers between healthcare providers and patients, ensuring hygiene and infection control during examinations or treatments.
Where is P.T. Tulip Indah Agung based?
The company is headquartered in the United States. This location allows it to comply with domestic regulatory requirements, including those governing medical device manufacturing and distribution.
How are P.T. Tulip Indah Agung’s devices classified under FDA regulations?
The company’s patient examination gloves fall under Class I device classification according to FDA regulations. This classification is typically assigned to devices posing minimal risk to users, as these gloves are designed for straightforward, low-risk applications like sterile barrier protection during medical examinations.
Are P.T. Tulip Indah Agung’s devices listed in any regulatory registries?
Yes, the company’s devices are listed via the FDA’s 510(k) pathway, which is a premarket submission required for Class I devices that are not exempt from regulatory controls. This process ensures compliance with FDA requirements before the devices enter the market.
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