Hanwella Rubber Products, Ltd.

Hanwella Rubber Products, Ltd. specializes in manufacturing powder-free latex patient examination gloves. These gloves are specifically designed for medical use, ensuring they meet the needs of clinical procedures where sterile or latex-compatible barriers are required.

Hanwella Rubber Products, Ltd. is headquartered in the United States. The company’s location ensures it operates within regulatory frameworks applicable to US-based medical device manufacturers.

Hanwella Rubber Products, Ltd.’s devices, such as their powder-free latex patient examination gloves, are classified as FDA Class I devices. This classification applies because the gloves are considered low-risk, non-invasive items that pose minimal potential harm to patients or users. Class I devices typically undergo general controls rather than stringent pre-market approvals.

Hanwella Rubber Products, Ltd.’s devices are listed in the FDA’s 510(k) registry. The 510(k) pathway is used for Class I devices that are substantially equivalent to legally marketed predicates, ensuring compliance with US regulatory requirements before commercial distribution.