Assurguard Sdn. Bhd.
MY Last updated 22 Oct 2026
- Devices
- 2
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Multiple Name Ref K123760
What Assurguard Sdn. Bhd. makes
Assurguard Sdn. Bhd. manufactures powder-free latex patient examination gloves in natural color, including those with protein content labeling claims. These gloves are designed for clinical and medical examination use to reduce allergic reactions and ensure compliance with protein content standards.
The company’s products are classified under Class I devices in the US and are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Frequently asked questions
What types of medical devices does Assurguard Sdn. Bhd. manufacture?
Assurguard Sdn. Bhd. specializes in manufacturing powder-free latex patient examination gloves in natural color. These gloves include variants with protein content labeling claims, designed specifically for clinical and medical examination use to minimize allergic reactions and meet regulatory protein content standards.
Where is Assurguard Sdn. Bhd. based?
Assurguard Sdn. Bhd. is based in the United States. The company’s headquarters and manufacturing operations are located within the country.
Which regulatory registries list Assurguard Sdn. Bhd.’s devices?
Assurguard Sdn. Bhd.’s devices are listed in the FDA’s 510(k) registry. This registry includes devices that have undergone a premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device.
How are Assurguard Sdn. Bhd.’s devices classified in the US?
Assurguard Sdn. Bhd.’s devices are classified under Class I in the United States. This classification is typically assigned to devices that pose minimal potential risk to users and are generally considered safe and effective when used as intended.
Information
- Country
- MY