Surgical Face Mask
by Xiantao Sanda Industrial Co., Ltd EUDAMED510(k)
Active
510(k) K222651
Overview
This device is a Surgical Face Mask, classified under product code FXX, designed to protect healthcare personnel and patients from airborne contaminants during surgical and medical procedures. It provides a barrier against droplets, splashes, and particulate matter, ensuring a sterile field and reducing the risk of infection transmission in clinical settings.
The mask is supplied as a single-use, non-sterile item, intended for use in operating rooms, clinical procedures, and other controlled environments where infection control is critical. It is regulated under FDA 510(k) clearance (K222651) and the EU Medical Device Regulation (MDR), adhering to standards for surgical protection. Sizes and packaging details are not specified in the data, but compliance with regulatory requirements ensures suitability for surgical applications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK222651 | Date13 Dec 2022 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- FXX
- FDA applicant
- Xiantao Sanda Industrial Co., Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4040
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Other devices from Xiantao sanda industrial CO., LTD
Questions
What is the primary purpose of this Surgical Face Mask in clinical settings?
This Surgical Face Mask is designed to create a barrier against airborne contaminants, including droplets, splashes, and particulate matter, to protect both healthcare personnel and patients during surgical and medical procedures. Its use helps maintain a sterile field and minimizes the risk of infection transmission in controlled environments like operating rooms and clinical procedures.
Is this mask intended for reuse, or is it meant to be used only once?
The mask is explicitly labeled as a single-use item, meaning it should not be reused after one application. This designation aligns with infection control best practices to ensure optimal protection and prevent cross-contamination in clinical settings.
How is this mask regulated, and what does that mean for its use in healthcare?
This Surgical Face Mask holds FDA 510(k) clearance (K222651) and complies with the EU Medical Device Regulation (MDR), confirming it meets stringent safety and performance standards for surgical protection. The clearance indicates it is deemed *substantially equivalent* to a predicate device, ensuring its suitability for use in operating rooms and other controlled medical environments where infection control is critical.
Is this mask sterile when supplied, or does it require additional processing before use?
The mask is supplied as non-sterile, meaning it does not undergo terminal sterilization before packaging. Clinicians should follow standard decontamination protocols (e.g., cleaning hands, using sterile gloves) before handling and applying it to maintain a sterile field during procedures.