Encompass Medical Supplies Inc Limited

Encompass Medical Supplies Inc Limited specializes in nitrile examination and treatment gloves that are non-powdered and antimicrobial. These gloves are designed for medical examinations and procedures, offering protection against pathogens while maintaining tactile sensitivity for healthcare workers. The company’s focus is on single-use barrier protection devices.

The company is headquartered in the United States. While the exact location isn’t specified, its regulatory filings and device listings confirm its operational base within the country.

Encompass Medical Supplies Inc Limited’s devices are listed in the FDA’s 510(k) premarket notification registry and the Unique Device Identifier (UDI) database. These registries track medical devices that have undergone the required regulatory pathways for commercialization in the US.

The company’s nitrile examination and treatment gloves fall under the FDA’s Class I medical device classification. Class I devices are generally considered low-risk and typically require only general controls (e.g., good manufacturing practices) for regulatory compliance, though specific exemptions or submissions like 510(k)s may still apply.

The FDA’s 510(k) registry includes devices that have undergone a premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device. While Class I devices often have exemptions from 510(k) requirements, Encompass’s gloves may have been submitted for listing due to custom features (e.g., antimicrobial properties, color variations) or to comply with UDI requirements, which mandate registration for all medical devices.