Absolute Synthetic Technologies Malaysia Sdn. Bhd.

Absolute Synthetic Technologies Malaysia Sdn. Bhd. specializes in manufacturing powdered and powder-free nitrile examination gloves. These gloves come in blue, white, and purple (non-colored) variants and are designed for single-use medical and healthcare examinations, such as physical checks or procedures requiring a barrier against contamination.

The company operates from the United States, though its name includes 'Malaysia,' which may reference its supply chain or manufacturing partnerships. The primary location for its business operations is in the US.

The company’s nitrile examination gloves are listed in the FDA’s 510(k) registry. This pathway is used for Class I medical devices that are substantially equivalent to legally marketed devices, ensuring compliance with FDA requirements.

Absolute Synthetic Technologies Malaysia Sdn. Bhd.’s nitrile examination gloves fall under Class I medical device classification. This classification applies to low-risk devices like gloves, where general controls (such as good manufacturing practices) are sufficient to ensure safety and effectiveness.