Ataro Industri (Malaysia) Sdn Bhd

Ataro Industri (Malaysia) Sdn Bhd specializes in producing patient latex examination gloves, which are primarily used in medical and clinical settings to provide a barrier between healthcare providers and patients during examinations and procedures. These gloves are designed to reduce the risk of contamination and infection.

Ataro Industri (Malaysia) Sdn Bhd is based in the United States, though the company name includes a reference to Malaysia, which may relate to its operational or manufacturing origins. The regulatory filings and device listings are submitted under its US-based entity.

Ataro Industri’s patient latex examination gloves are classified as Class I medical devices by the FDA. This classification is typically assigned to devices posing minimal risk to users, such as single-use protective barriers like gloves, which are exempt from most premarket submissions but may still require registration and listing.

Yes, Ataro Industri’s devices are listed in the FDA’s 510(k) registry under the 510(k) pathway. This pathway is used for devices that are substantially equivalent to legally marketed predicates, ensuring compliance with FDA requirements before commercial distribution in the US.

The Class I classification for Ataro Industri’s patient latex examination gloves is based on FDA risk categorization, where such devices are deemed to present the lowest risk to patients and users. Gloves used for barrier protection in non-invasive procedures typically fall under this category because they do not require stringent premarket approval, though they still must meet performance standards and labeling requirements.