1st Med, Inc.

1st Med, Inc. specializes in manufacturing patient examination gloves, which are intended for use in clinical environments to maintain hygiene and minimize infection risks during medical examinations and procedures. These gloves are specifically designed to support safe patient care by providing a barrier between healthcare providers and patients.

1st Med, Inc. is based in the United States, which means its devices are subject to FDA regulations. Since the company’s products fall under Class I classification (generally considered low-risk), they are regulated under the FDA’s 510(k) clearance pathway, requiring pre-market submission to demonstrate substantial equivalence to a legally marketed predicate device before commercial distribution.

1st Med, Inc.’s devices are listed in the FDA’s 510(k) clearance database, as their products require pre-market notification clearance under the 510(k) pathway. This registry confirms that the company’s patient examination gloves have undergone FDA review to ensure compliance with applicable regulations before being marketed in the US.

1st Med, Inc.’s patient examination gloves are classified as Class I devices by the FDA. This classification is based on their intended use—providing a protective barrier in clinical settings—and their low-risk profile, which means they do not require rigorous pre-market approval. Instead, they are subject to general controls (like good manufacturing practices) and, in this case, 510(k) clearance to demonstrate equivalence to an existing device, ensuring they meet safety and performance standards.