Chinteik Hygiene Products Co., Ltd.

Chinteik Hygiene Products Co., Ltd. specializes in manufacturing rubber condom contraceptives. These devices are designed to provide a barrier method of contraception during sexual intercourse, preventing unintended pregnancies and reducing the risk of sexually transmitted infections.

The company is headquartered in the United States. This location influences its regulatory compliance, particularly under U.S. medical device regulations.

The company’s rubber condom contraceptives fall under Class II device classification in the U.S. This classification requires 510(k) clearance before marketing, as they pose moderate risk and require general controls plus special controls to ensure safety and effectiveness. The classification reflects their role as barrier contraceptives, which require validation of performance and manufacturing consistency.

Yes, the company’s devices are included in the FDA’s 510(k) database. This registry documents devices that have undergone the required premarket notification process, demonstrating compliance with U.S. regulatory requirements before commercial distribution. Listing in this database is a public record of the device’s clearance status.