Cashmor Mfg. , Ltd.

Cashmor Mfg., Ltd. specializes in manufacturing Shannon latex medical gloves. These gloves are intended for single-use as protective barriers in clinical and procedural environments, helping to reduce the risk of contamination during medical procedures.

Cashmor Mfg., Ltd. is headquartered in the United States. The company’s location in the US ensures compliance with regional regulatory standards and facilitates distribution within North America.

Cashmor Mfg., Ltd.’s Shannon latex medical gloves fall under Class I device classification according to FDA regulations. This classification applies to devices posing minimal risk, typically those with well-established safety profiles and low potential for harm, such as single-use gloves. Class I devices often require less stringent premarket review compared to higher-risk categories.

Yes, Cashmor Mfg., Ltd.’s Shannon latex medical gloves are listed via the FDA’s 510(k) pathway. This pathway is used for devices that are substantially equivalent to legally marketed predicates, demonstrating that they meet the same safety and performance criteria without requiring a full premarket approval process. The listing confirms the device’s compliance with applicable FDA regulations.