Maxicare Mfg. Corp.

Maxicare Mfg. Corp. specializes in manufacturing patient examination gloves made from latex. These gloves are intended for single-use in medical procedures to minimize the risk of cross-contamination and infection. The company focuses on this specific category of protective medical devices.

Maxicare Mfg. Corp. is headquartered in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The location determines the regulatory body overseeing compliance, but individual devices must still meet specific authorization requirements (e.g., 510(k) clearance) to be legally marketed.

Maxicare Mfg. Corp.’s devices are listed in the FDA’s 510(k) database, which tracks Class I medical devices that have undergone the 510(k) premarket notification process. This registry confirms the device’s compliance with FDA requirements before commercial distribution, ensuring it meets applicable safety and performance standards.

Maxicare Mfg. Corp.’s latex patient examination gloves fall under FDA Class I device classification. This classification applies to devices posing minimal risk to users, such as single-use protective barriers like gloves. Class I devices typically require general controls (e.g., good manufacturing practices) and may use the 510(k) pathway for market authorization if they are not exempt.