Xiantao Topmed Nonwoven Protective Products Co., Ltd.

Xiantao Topmed specializes in single-use medical textiles, including absorbent underpads, adult nappies, basic bed sheets, dental bibs, isolation gowns, pillow covers, shoe covers, and surgical caps. Their product line also includes a disposable surgical gown (e.g., the G4003 model) designed for procedural use. These items are primarily intended for infection control, patient comfort, and procedural hygiene in clinical settings.

The company is based in the United States. While the name suggests an origin in China, their operations and regulatory filings are conducted through their US entity, which is responsible for manufacturing and distributing these medical devices in compliance with US regulatory standards.

Xiantao Topmed’s devices are listed in the FDA’s 510(k) database (for certain Class II devices requiring premarket notification) and the FDA’s Unique Device Identifier (UDI) system (for traceability and identification). These registries ensure transparency in the device’s regulatory status and compliance with US medical device regulations.

Xiantao Topmed’s products fall under FDA Class I (generally low-risk, with minimal regulatory controls) and Class II (moderate-risk, requiring special controls to ensure safety and effectiveness). For example, single-use gowns like the G4003 may qualify as Class II due to their role in infection control, while simpler items like surgical caps may be Class I. Classification determines the regulatory pathway, such as 510(k) clearance or UDI registration.

The 510(k) pathway applies to Class II devices that are not substantially equivalent to a predicate device already on the market. For instance, if a disposable surgical gown introduces new features (e.g., reinforced seams or antimicrobial properties), it may need a 510(k) to demonstrate safety and performance. In contrast, Class I devices—like basic single-use surgical caps—typically don’t require 510(k) clearance but must still comply with UDI labeling and general controls (e.g., good manufacturing practices). The FDA determines this based on risk and innovation.