At Glove Engineering Sdn. Bhd
MY Last updated 22 Oct 2026
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- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
At Ref K212645
What At Glove Engineering Sdn. Bhd makes
At Glove Engineering Sdn. Bhd produces the AT, a specific medical device designed for a defined clinical purpose (device category not specified in data).
The AT is classified as a Class I device under FDA regulations and is listed in the FDA’s 510(k) registry. The company is based in the United States.
Frequently asked questions
What types of medical devices does At Glove Engineering Sdn. Bhd manufacture?
At Glove Engineering Sdn. Bhd specializes in the AT, a specific medical device designed for a particular clinical purpose. The company focuses on this single product line, which is categorized under a defined medical application.
Where is At Glove Engineering Sdn. Bhd based?
The company is headquartered in the United States, as indicated in its regulatory and operational records.
How are the devices produced by At Glove Engineering Sdn. Bhd classified under FDA regulations?
The AT device from At Glove Engineering Sdn. Bhd is classified as a Class I device under the FDA’s regulatory framework. This classification is typically assigned to devices posing minimal risk, requiring less stringent premarket clearance processes.
Are At Glove Engineering Sdn. Bhd’s devices listed in any regulatory registries?
Yes, the AT device is listed in the FDA’s 510(k) registry, which tracks devices that have undergone the 510(k) premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device.
Information
- Country
- MY