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Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K211832

by Zhejiang Lanhine Medical Products Ltd.

Identifiers

510(k) Number
K211832 FDA 510(k)
FDA Product Code
FXX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4040 FDA 510(k)
Regulation Number
878.4040 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Fluid Resistant Surgical Mask and Fluid Resistant Procedure Mask, classified under product code FXX. It is designed to provide barrier protection against liquid penetration, ensuring respiratory hygiene by filtering airborne particles and preventing contamination from splashes or sprays during medical procedures. The mask is engineered to meet standards for fluid resistance, offering enhanced safety for both healthcare providers and patients in clinical settings.

The mask is supplied as a single-use, non-sterile item and is intended for use in surgical and procedural environments where fluid resistance is critical. It is regulated under the FDA’s 510(k) clearance process, determined to be Substantially Equivalent to a predicate device, and complies with the EU Medical Device Regulation (MDR). Sizes and configurations are standardized for universal fit, ensuring ease of application and compliance with infection control protocols.

Frequently asked questions

What types of medical environments is this mask designed for, and why is fluid resistance important in those settings?

This mask is specifically designed for surgical and procedural environments where protection against liquid penetration is critical. Fluid resistance ensures that healthcare providers remain shielded from splashes, sprays, or airborne particles during procedures, reducing the risk of contamination for both the wearer and patients. This is particularly important in surgeries or treatments involving fluids, such as in plastic surgery or other high-risk procedures where infection control is paramount.

Is this mask reusable, or is it intended for single-use only? How does this affect its use in clinical settings?

This mask is explicitly supplied as a single-use item, meaning it is not intended for reuse after a single application. This design aligns with infection control protocols, as single-use masks minimize the risk of cross-contamination between patients and healthcare providers. In clinical settings, this ensures hygiene standards are maintained, reducing the potential for microbial transmission.

What sizes or configurations are available, and how do they ensure a universal fit for healthcare workers?

The mask is supplied in standardized sizes and configurations designed for a universal fit, accommodating most users without the need for customization. This approach simplifies inventory management for healthcare facilities and ensures ease of application, reducing the time spent adjusting masks during procedures. The universal design also helps maintain consistent protection levels across different users.

How should this mask be stored, and does its non-sterile status impact its handling or shelf life?

While the mask is non-sterile, it should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, or sources of contamination to preserve its integrity. Proper storage ensures the fluid-resistant properties remain effective until use. The non-sterile classification means it does not require sterile packaging, but it should still be handled in a manner that prevents pre-use contamination, such as avoiding contact with surfaces or hands before application.

What regulatory pathways does this mask follow, and how does that affect its availability in different markets?

This mask has undergone FDA 510(k) clearance and complies with the EU Medical Device Regulation (MDR), meaning it is approved for use in the United States and the European Economic Area. The FDA determined it to be Substantially Equivalent to a predicate device, while the MDR ensures it meets stringent EU safety and performance standards. These regulatory pathways confirm its suitability for clinical use in both markets, though buyers should verify local compliance requirements before procurement.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Zhejiang Lanhine Medical Products Ltd.
FDA Applicant
Zhejiang Lanhine Medical Products, Ltd.

Sources (2)

  • FDA 510(k) K211832 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026