Aik Poh Rubber Industries Sdn. Bhd.
Malaysia(FDA 510(k) applicant) Last updated 22 Oct 2026
- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Patient Examination Gloves (Latex) Ref K892626
What Aik Poh Rubber Industries Sdn. Bhd. makes
The company manufactures latex patient examination gloves, designed for clinical use during medical procedures and examinations.
These gloves are classified as Class I devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Frequently asked questions
What types of medical devices does Aik Poh Rubber Industries Sdn. Bhd. manufacture?
Aik Poh Rubber Industries Sdn. Bhd. specializes in manufacturing latex patient examination gloves, which are intended for clinical use during medical procedures and examinations. These gloves are designed to provide a barrier between healthcare providers and patients to reduce the risk of infection or contamination.
Where is Aik Poh Rubber Industries Sdn. Bhd. based?
The company is headquartered in the United States. This location is relevant for regulatory compliance and distribution, particularly for devices marketed in North America.
How are the company’s devices classified under FDA regulations?
The company’s latex patient examination gloves are classified as Class I devices by the FDA. This classification applies because the gloves pose minimal risk to patients and are considered low-risk medical devices, requiring less stringent regulatory oversight compared to higher-risk categories.
Which regulatory registries or databases list the company’s devices?
The company’s latex patient examination gloves are listed via the FDA’s 510(k) pathway, meaning they have been determined to be substantially equivalent to a legally marketed predicate device. This listing ensures compliance with U.S. regulatory requirements for Class I devices.
Information
- Country
- Malaysia