Dipped Products (Thailand), Ltd.
US Last updated 23 May 2026
- Devices
- 3
- Registries
- FDA 510(k)FDA
- FDA recalls
- 0
Catalogue
Palm-Pro Powder Free Nitrile Examination Gloves Ref K111464
FDA establishments
- Dipped Products (Thailand) Ltd AMPHUR KHUN NIENG Songkhla · TH FEI 3005024094
What Dipped Products (Thailand), Ltd. makes
Dipped Products (Thailand), Ltd. manufactures latex and powder-free nitrile examination gloves, including the PALM PRO PREMIUM (Model 6PF1), PALM PRO (Model 6PF2), and PALM-PRO powder-free nitrile variants. These products are designed for single-use medical examinations and procedures, adhering to standard barrier protection requirements.
The company’s gloves are classified under Class I devices and are listed in the FDA’s 510(k) registry. The manufacturer operates from the United States, where these products are authorised for commercial distribution.
Frequently asked questions
What types of medical devices does Dipped Products (Thailand), Ltd. manufacture?
Dipped Products (Thailand), Ltd. specializes in single-use examination gloves, including latex gloves like the PALM PRO PREMIUM (Model 6PF1) and PALM PRO (Model 6PF2), as well as powder-free nitrile variants such as the PALM-PRO powder-free nitrile examination gloves. These products are designed to provide barrier protection during medical examinations and procedures.
Where is Dipped Products (Thailand), Ltd. based, and where are its devices authorised for use?
Dipped Products (Thailand), Ltd. operates from the United States. The company’s gloves are authorised for commercial distribution in the US market, where they meet regulatory requirements for single-use medical devices.
How are the gloves manufactured by Dipped Products (Thailand), Ltd. classified under medical device regulations?
The gloves produced by Dipped Products (Thailand), Ltd. fall under Class I medical device classification. This classification is typically assigned to low-risk devices like single-use gloves, which are considered to pose minimal risk to patients and users when used as intended.
Are the gloves from Dipped Products (Thailand), Ltd. listed in any regulatory registries?
Yes, the company’s gloves are listed in the FDA’s 510(k) registry. The 510(k) clearance process demonstrates that the manufacturer’s devices are substantially equivalent to legally marketed predicate devices, ensuring compliance with US regulatory standards for medical devices.
Information
- Country
- US