P.T. Healthcare Glovindo

P.T. Healthcare Glovindo specializes in manufacturing examination gloves for medical and patient use. Their product line includes latex gloves (both powder-free and pre-powdered with low protein claims), powder-free patient examination gloves, and powder-free nitrile examination gloves. Some gloves feature specific protein content labeling, such as latex gloves with ≤180 µg of protein per orifice or nitrile gloves with ≤50 micrograms of protein, to minimize allergic reactions.

P.T. Healthcare Glovindo is based in the United States. Their devices are designed and regulated under U.S. medical device laws, ensuring compliance with local safety and performance standards.

P.T. Healthcare Glovindo’s examination gloves are listed in the FDA’s 510(k) clearance registry. This classification confirms that their devices have undergone the necessary regulatory pathway to demonstrate substantial equivalence to a legally marketed predicate device under U.S. medical device regulations.

P.T. Healthcare Glovindo’s examination gloves fall under Class I medical devices in the U.S. This classification applies to low-risk devices like single-use gloves, where general controls (such as good manufacturing practices) are sufficient to ensure safety and effectiveness. Class I devices typically require less stringent premarket review compared to higher-risk categories.