Disposable Surgical Face Mask (FM-34EE, FM-44EE)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Face Mask EUDAMED
- Device Name
- Face Mask EUDAMED
- Model / Reference
- FOB-A, FOB-B, FOB-C, FOB-D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974622960001 EUDAMED
- Basic UDI-DI
- 697473536KUB18PS EUDAMED
- 510(k) Number
- K220597 FDA 510(k)
- FDA Product Code
- FXX FDA 510(k)
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4040 FDA 510(k)
- Regulation Number
- 878.4040 FDA 510(k)
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
Yes
Near-Patient Testing
Yes
Professional Testing
Yes
Companion Diagnostics
Yes
Surgical Instrument
Yes
New Device
No
This device is a Disposable Surgical Face Mask, designed to provide barrier protection for healthcare personnel and patients during surgical and medical procedures. It is classified under the FXX product code and adheres to standards for fluid resistance and filtration efficiency, ensuring minimal particle and droplet transmission.
The masks are supplied as single-use, non-sterile items intended for use in surgical and clinical settings. They are regulated under FDA 510K and IVDR compliance, with clearance granted as Substantially Equivalent to predicate devices. Sizes are specified by model (FM-34EE, FM-44EE), and proper storage requires protection from moisture and contamination to maintain integrity.
Frequently asked questions
Are these masks intended for reuse, or are they strictly single-use only? Why does that matter?
These masks are explicitly labeled as single-use only, meaning they should not be reused after a single procedure. This is critical because surgical masks are designed to maintain barrier protection and filtration efficiency only for one use. Reuse could compromise integrity, increase contamination risk, and reduce effectiveness in blocking particles and droplets, which is especially important in sterile surgical environments.
What distinguishes the FM-34EE model from the FM-44EE model, and how should I choose between them?
The models FM-34EE and FM-44EE are differentiated by size, as indicated by the model designation. While the exact dimensions aren’t provided, the numeric suffix typically correlates to variations in fit (e.g., adult vs. pediatric or different facial contours). Selection should be based on the user’s facial anatomy to ensure a secure seal, as an improper fit may reduce protection efficacy. Check the packaging or manufacturer’s sizing guide for precise fit recommendations.
How should I store these masks to ensure they remain effective when needed?
These masks must be stored in a dry, clean environment protected from moisture and contamination to preserve their structural integrity and filtration properties. Exposure to humidity or dirt can degrade the material, compromising their ability to block particles and droplets. Store them in their original packaging, away from direct sunlight or heat sources, and ensure the seals remain intact until use.
Are these masks sterile, and if not, what precautions should I take when using them?
No, these masks are non-sterile and are not intended for sterile procedures. While they provide barrier protection against droplets and particles, they are not processed to eliminate microorganisms. To minimize infection risk, follow standard surgical aseptic techniques (e.g., hand hygiene, sterile gloving) when handling the mask and the patient. Reserve sterile masks for procedures requiring a sterile field.
What regulatory pathways have these masks undergone, and what does that mean for their safety and compliance?
These masks have been cleared under FDA’s 510(k) pathway as *Substantially Equivalent* to predicate devices, meaning they meet the same performance standards for fluid resistance and filtration efficiency. They also comply with the EU’s In Vitro Diagnostic Regulation (IVDR), though this may relate to testing methodologies rather than direct clinical use. The clearance ensures they meet U.S. safety and effectiveness requirements for surgical masks, but always verify compliance with local regulations before use.
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
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K220597 | Class II | Active |
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Manufacturer
- Manufacturer
- Qingdao Bestex Rubber & Plastic Products Co., Ltd.
Sources (3)
- FDA 510(k) K220597 24 fields · synced Oct 6, 2026
- EUDAMED 5ef03643-8f8e-49f3-b9a0-44c1c571b9a5-1 61 fields · synced Jul 20, 2026
- EUDAMED 5ef03643-8f8e-49f3-b9a0-44c1c571b9a5-2 61 fields · synced Jul 20, 2026