Avecena Gloves Sdn Bhd
MY Last updated 22 Oct 2026
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- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
What Avecena Gloves Sdn Bhd makes
Avecena Gloves Sdn Bhd manufactures single-use disposable gloves, including latex and nitrile varieties. The Glovatex™ White Latex Gloves and Glovanil™ Blue Nitrile Gloves are designed for medical and industrial applications requiring barrier protection.
These products are classified as Class I medical devices under regulatory frameworks. They are listed in the FDA’s 510(k) registry, indicating compliance with pre-market notification requirements. The company is based in the United States.
Frequently asked questions
What types of medical devices does Avecena Gloves Sdn Bhd manufacture?
Avecena Gloves Sdn Bhd specializes in single-use disposable gloves, including latex and nitrile varieties. Their products, such as the Glovatex™ White Latex Gloves and Glovanil™ Blue Nitrile Gloves, are designed for medical and industrial applications where barrier protection is required.
Where is Avecena Gloves Sdn Bhd based?
The company is headquartered in the United States. This location is relevant for understanding regulatory oversight and compliance frameworks applicable to their products.
How are Avecena Gloves Sdn Bhd’s devices classified under regulatory standards?
The company’s gloves, such as the Glovatex™ and Glovanil™ lines, are classified as Class I medical devices. This classification is typically assigned to low-risk devices that pose minimal potential harm to users, allowing for streamlined regulatory pathways.
Which regulatory registries list Avecena Gloves Sdn Bhd’s devices?
The company’s devices, including the Glovatex™ and Glovanil™ gloves, are listed in the FDA’s 510(k) registry. This registry tracks devices that have undergone pre-market notification (510(k)) submissions, demonstrating compliance with U.S. regulatory requirements before commercial distribution.
Information
- Country
- MY