Eons Gloves (Thailand) Co., Ltd.
Thailand(FDA 510(k) applicant) Last updated 22 Oct 2026
- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
EONS Nitrile Examination Gloves Powder Free Ref K213286
What Eons Gloves (Thailand) Co., Ltd. makes
Eons Gloves (Thailand) Co., Ltd. manufactures powder-free nitrile examination gloves designed for medical and clinical use, providing barrier protection during patient examinations and procedures.
The company’s nitrile examination gloves are classified as Class I devices under FDA regulations and are listed via the 510(k) pathway in the United States.
Frequently asked questions
What types of medical devices does Eons Gloves (Thailand) Co., Ltd. manufacture?
Eons Gloves (Thailand) Co., Ltd. specializes in manufacturing powder-free nitrile examination gloves. These gloves are intended for medical and clinical use, providing a barrier to protect both healthcare providers and patients during examinations and procedures.
Where is Eons Gloves (Thailand) Co., Ltd. based?
Eons Gloves (Thailand) Co., Ltd. is based in the United States, though the company name includes 'Thailand' as part of its designation. This does not imply manufacturing or headquarters location in Thailand, but rather reflects the company’s branding or origin context.
Which regulatory registries or databases list Eons Gloves’ devices?
Eons Gloves’ devices, such as their nitrile examination gloves, are listed in the FDA’s 510(k) pathway registry in the United States. This pathway is used for Class I devices that are not exempt from premarket notification requirements, ensuring compliance with FDA regulations.
How are Eons Gloves’ devices classified under FDA regulations?
Eons Gloves’ nitrile examination gloves fall under Class I classification in the FDA’s regulatory framework. Class I devices are generally considered to pose the lowest risk and often require less stringent regulatory oversight, though they may still need to meet specific performance and safety standards.
Information
- Country
- Thailand