| Registration code | Remark |
| FXO | The 510(k) exemption codes for mask products include KHA, FXO, and QKR; our medical protective masks are registered under code QKR. Each registration code corresponds to a specific category of product usage: 1. Code QKR is described as covering masks used by healthcare personnel for virus protection, excluding KN95 masks. 2. Codes QKR and FXO cover general medical masks. 3. Medical surgical masks and medical protective masks have their own specific 510(k) codes (distinguishing between sterile and non-sterile versions). 4. Code KHA generally applies to respiratory masks, such as standard anesthesia masks. |
With a mature R&D system, modern production equipment, and standardized manufacturing processes, we continuously improve product design and production technology to ensure consistent quality, reliable performance, and compliance with international standards.
From product selection to delivery coordination, our process is shaped around dependable quality and practical healthcare applications.
Product details are organized for consistent selection and professional use.
Manufacturing support is aligned with healthcare product requirements.
Flexible supply options help match different application and distribution needs.
Products are selected for practical operation and dependable application value.
Clear coordination helps improve order handling and delivery efficiency.
Timely communication supports product inquiry, matching, and after-sales needs.
We follow strict international quality standards throughout raw material sourcing, manufacturing, and final inspection to ensure consistent quality, reliable performance, and compliance with global medical device requirements.
