P.T. Latexindo Tobaperkasa
ID Last updated 22 Oct 2026
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- Devices
- 3
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Pre-Powdered Nitrile Examination Gloves Ref K974442
What P.T. Latexindo Tobaperkasa makes
P.T. Latexindo Tobaperkasa manufactures single-use examination gloves, including pre-powdered nitrile gloves, powder-free latex gloves with a high-coat finish, and polymer-coated powder-free nitrile gloves. These products are designed for patient and healthcare professional use in clinical settings to reduce contamination risk and improve comfort during procedures.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded in the FDA’s 510(k) clearance registry. The manufacturer operates from the United States.
Frequently asked questions
What types of medical devices does P.T. Latexindo Tobaperkasa manufacture?
P.T. Latexindo Tobaperkasa manufactures single-use examination gloves for both patient and healthcare professional use. Their portfolio includes pre-powdered nitrile gloves, powder-free latex gloves with a high-coat finish, and polymer-coated powder-free nitrile gloves. These products are designed to reduce contamination risk and enhance comfort during clinical procedures.
Where is P.T. Latexindo Tobaperkasa based?
The company operates from the United States, as indicated in their regulatory documentation.
Which regulatory registries list P.T. Latexindo Tobaperkasa’s devices?
The company’s devices are recorded in the FDA’s 510(k) clearance registry, which tracks submissions for medical devices classified under FDA regulations.
How are P.T. Latexindo Tobaperkasa’s devices classified under FDA regulations?
The manufacturer’s examination gloves fall under Class I and Class II classifications. Class I devices generally pose minimal risk and may require less regulatory oversight, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification is determined by factors like intended use, potential harm, and the duration of contact with the body.
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