Aliga Export Sdn Bhd
MY Last updated 22 Oct 2026
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- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Latex Examination Gloves Ref K893284
What Aliga Export Sdn Bhd makes
Aliga Export Sdn Bhd manufactures latex examination gloves, designed for medical and clinical use to ensure sterile protection during examinations and procedures.
These products are classified as Class I medical devices and are listed under the FDA’s 510(k) pathway. The company is based in the United States.
Frequently asked questions
What types of medical devices does Aliga Export Sdn Bhd manufacture?
Aliga Export Sdn Bhd specializes in manufacturing latex examination gloves. These gloves are intended for medical and clinical use, providing sterile protection during examinations and procedures. The focus is on ensuring safety and hygiene in healthcare settings.
Where is Aliga Export Sdn Bhd based?
Aliga Export Sdn Bhd is based in the United States. The company’s location in the US allows it to comply with relevant regulatory standards and market requirements for its medical devices.
How are the devices manufactured by Aliga Export Sdn Bhd classified?
The latex examination gloves produced by Aliga Export Sdn Bhd are classified as Class I medical devices. This classification is typically assigned to devices posing minimal risk to users, as determined by regulatory authorities. Class I devices often undergo general controls rather than requiring pre-market approval.
Are Aliga Export Sdn Bhd’s devices listed in any regulatory registries?
Yes, Aliga Export Sdn Bhd’s latex examination gloves are listed under the FDA’s 510(k) pathway. This means the devices have been evaluated and determined to be substantially equivalent to a legally marketed predicate device, allowing them to enter the US market under this regulatory framework.
Information
- Country
- MY