Amazing Rubber Products Pvt, Ltd.

Amazing Rubber Products Pvt, Ltd. specializes in single-use examination gloves and sterile surgical gloves. Their product line includes powder-free nitrile and latex examination gloves, as well as sterile latex surgical gloves designed for healthcare and industrial use. These gloves are intended for protective barrier applications in medical and non-medical settings.

The company is headquartered in the United States. This location is relevant for regulatory oversight, as their devices are subject to U.S. regulatory requirements, including those managed by the FDA.

The company’s devices are listed in the FDA’s 510(k) clearance database. This registry includes records for devices that have undergone FDA review and received clearance under the 510(k) pathway, which is common for Class I medical devices that pose minimal risk.

All of Amazing Rubber Products Pvt, Ltd.’s listed devices fall under FDA Class I classification. This classification applies to devices that are considered low-risk and generally do not require pre-market approval, though they may still need to comply with specific labeling, manufacturing, and quality system regulations.