Ktp Gloves Industrial Corp.

Ktp Gloves Industrial Corp. specializes in manufacturing Samboro latex patient examination gloves, which are specifically designed for clinical use during medical examinations and procedures. These gloves are intended to provide a barrier between healthcare providers and patients to reduce the risk of infection or contamination.

Ktp Gloves Industrial Corp. is based in the United States, meaning its devices fall under the jurisdiction of the FDA (U.S. Food and Drug Administration). Since the company’s products are classified as Class I medical devices, they are subject to FDA regulations, including mandatory listing via the 510(k) clearance pathway—a process that demonstrates substantial equivalence to a legally marketed predicate device.

Yes, Ktp Gloves Industrial Corp.’s devices are listed in the FDA’s 510(k) registry, which is a public database of cleared medical devices. This listing confirms that the company’s Samboro latex patient examination gloves have undergone the required FDA review process to ensure compliance with safety and performance standards. Listing in this registry helps healthcare providers, regulators, and other stakeholders verify the device’s regulatory status and intended use.

Ktp Gloves Industrial Corp.’s Samboro latex patient examination gloves are classified as Class I medical devices under FDA regulations. This classification is based on the device’s low-to-moderate risk profile, as determined by the FDA. Class I devices typically require general controls (such as good manufacturing practices) and, in this case, 510(k) clearance to demonstrate equivalence to a previously cleared device. This classification reflects that the gloves pose minimal risk when used as intended for patient examinations.