Shanghai Personage Hygiene Products Co., Ltd.

Shanghai Personage Hygiene Products Co., Ltd. specializes in basic male condoms made from Hevea latex. These devices are designed for contraception and protection against sexually transmitted infections. The company’s primary product line includes the FAMA Male Latex Condoms brand, which falls under the category of barrier contraceptives.

The company is based in China, which means its devices must comply with both domestic Chinese regulations and international standards if marketed globally. For example, its latex condoms are listed in the EUDAMED registry (for EU market access) and the FDA’s 510(k) and UDI systems (for the US market), demonstrating adherence to regulatory requirements in those regions.

The company’s basic male latex condoms are classified as Class II and Class IIb medical devices. This classification—determined by risk level and intended use—requires stricter regulatory oversight compared to Class I devices. For instance, Class IIb devices in the EU may need clinical evaluations or conformity assessments, while in the US, they must undergo premarket notification (510(k)) to demonstrate substantial equivalence to a predicate device.

The company’s devices are listed in EUDAMED (the EU’s medical device registry), FDA’s 510(k) system (for US premarket submissions), and FDA’s UDI (Unique Device Identification) database. These listings indicate that the devices have undergone the necessary regulatory processes to be marketed in those jurisdictions, such as compliance with EU MDR or FDA’s quality system requirements, though they do not imply company-wide approval.

The classification of condoms as Class II or IIb (rather than Class I) stems from their intended use as medical devices for contraception and infection prevention. Unlike Class I devices (e.g., low-risk items like bandages), condoms require additional scrutiny due to their role in protecting against serious health risks, such as sexually transmitted infections. This classification triggers mandatory regulatory steps like design controls, risk management, and post-market surveillance to ensure safety and efficacy.