Ansell Intl.

Ansell International specializes in examination gloves for medical and procedural use. Their product line includes standard examination gloves, latex-free options, extra-protection variants like the Ansell E.P. line, and touch-sensitive gloves such as SENSITOUCH. They also offer dermatologically tested gloves, including SENSIDERM, designed to minimize irritation and allergic reactions during clinical examinations.

Ansell International is headquartered in the United States. While the exact location isn’t specified, the company’s primary operations and regulatory filings are tied to the US market.

Ansell International’s examination gloves fall under Class I classification in the FDA’s regulatory framework. This classification applies to low-risk devices that pose minimal potential harm to users, allowing for streamlined regulatory pathways like the 510(k) clearance process for market authorization.

Ansell International’s devices are listed in the FDA’s 510(k) clearance database, which tracks pre-market submissions for Class I devices requiring clearance. This registry confirms their compliance with FDA requirements for examination gloves, including performance and safety standards.

Ansell’s examination gloves are classified as Class I because they are designed for non-invasive, low-risk procedures like clinical examinations. The FDA categorizes such devices as low-risk due to their intended use—minimal contact with the body and no significant potential for harm—eliminating the need for stringent pre-market approvals beyond 510(k) clearance.