Surgical Face Mask
by Jiangsu Micsafe Medical Technology Co., Ltd
510(k) K202205
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK202205 | Date9 Mar 2021 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- FXX
- FDA applicant
- Jiangsu Micsafe Medical Technology Co., Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4040
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Surgical Face Mask is a disposable barrier device designed to protect the wearer’s mouth and nose from contamination by respiratory secretions, blood, and other bodily fluids during surgical and medical procedures. Classified under product code FXX, it adheres to regulatory standards for fluid resistance and filtration efficiency to ensure patient and healthcare worker safety.
This device is intended for single-use only and must not be reused after a single procedure. Supplied sterile in sealed packaging, it complies with FDA 510(k) clearance (K202205) and the Medical Device Directive (MDD). No additional sterilisation or reprocessing is required; proper disposal follows standard infection control protocols. The mask is manufactured by Jiangsu Micsafe Medical Technology Co., Ltd., based in Yancheng, Jiangsu Province, China.
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Questions
AI-generated answers, 18 Sep 2026
Is this mask suitable for reuse in multiple procedures, or is it strictly single-use only?
This Surgical Face Mask is explicitly designed for single-use only and must not be reused after a single procedure. The manufacturer and regulatory submissions (including FDA 510(k) clearance) emphasize this restriction to maintain sterility and prevent contamination risks. Reuse violates infection control protocols and could compromise patient and clinician safety.
How is the mask packaged and prepared for use, and does it require any additional sterilization?
The mask is supplied sterile in sealed packaging, so no additional sterilization is required before use. The packaging ensures barrier integrity until the first procedure. After opening, it must be used immediately and disposed of per standard infection control guidelines—no reprocessing is permitted.
What regulatory pathways does this mask follow, and how does that affect its use in clinical settings?
This mask follows FDA 510(k) clearance (K202205) under the Traditional pathway and complies with the Medical Device Directive (MDD). These approvals confirm it meets U.S. and EU standards for fluid resistance and filtration efficiency, ensuring it’s safe for surgical and medical procedures. The classification under product code FXX (General, Plastic Surgery) reflects its broad use in procedural settings, not a specific clinical indication.
Are there different sizes or models available for this mask, or is it a one-size-fits-all design?
The provided specifications do not detail specific sizes or models for this Surgical Face Mask, implying it may be a standardized design without size variations. For precise fit requirements (e.g., pediatric or adult), clinicians should verify with the manufacturer, Jiangsu Micsafe, as sizing details are not included in the regulatory data.