A1 Glove Sdn Bhd

A1 Glove Sdn Bhd specializes in manufacturing powder-free latex patient examination gloves. These gloves are specifically designed for medical and clinical use, such as during examinations or procedures. The key feature is their protein content labeling claim, ensuring the gloves contain 50 micrograms per dm² or less of water-extractable protein, which helps reduce the risk of allergic reactions in patients.

A1 Glove Sdn Bhd is based in the United States. Its devices fall under the Class I regulatory classification, which typically applies to low-risk medical products like examination gloves. In the US, these devices are listed through the 510(k) pathway, a regulatory submission process used to demonstrate substantial equivalence to a legally marketed predicate device.

A1 Glove Sdn Bhd’s devices are listed in the FDA’s 510(k) registry under the US regulatory framework. This registry tracks devices that have undergone the 510(k) clearance process, ensuring they meet applicable safety and performance standards before commercial distribution. The listing confirms the device’s compliance with regulatory requirements for its intended use.

The protein content claim on A1 Glove Sdn Bhd’s powder-free latex gloves is critical because natural rubber latex contains proteins that can trigger allergic reactions in sensitive individuals. By limiting the protein content to 50 micrograms per dm² or less, the gloves are designed to minimize allergenic risk, making them safer for patients with latex sensitivities. This feature aligns with medical best practices for reducing adverse reactions during clinical procedures.