Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Medical face mask EUDAMED
- Device Name
- Non-woven Face Mask Type II EUDAMEDNon-woven Face Mask Type IIR EUDAMED
- Model / Reference
- 15910000 EUDAMED15910001 EUDAMED15841115 EUDAMEDUM120T EUDAMEDUM01 EUDAMEDUM120 EUDAMED15841135 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973490853026 EUDAMED06973490853040 EUDAMED06973490850100 EUDAMED06973490857147 EUDAMED06973490856867 EUDAMED06973490855532 EUDAMED06973490850148 EUDAMED06973490859950 EUDAMED
- Basic UDI-DI
- 697349085UMMASK2E EUDAMED697349085UMMASKRDG EUDAMED
- 510(k) Number
- K220749 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 I 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
- Finland EUDAMEDItaly EUDAMEDIreland EUDAMEDBulgaria EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
This device is a surgical face mask designed to provide barrier protection against airborne contaminants and splashes during surgical and medical procedures. Constructed with a disposable, non-woven fabric filter layer, it is intended for single-use in clinical settings to reduce the risk of infection transmission from the wearer to patients or healthcare personnel.
The mask is supplied sterile in individual packaging and features an ear-loop design for secure positioning. Measuring 17.5 cm × 9.5 cm, it complies with FDA 510(k) clearance (K220749) and EU MDR requirements, ensuring regulatory conformity for use in surgical environments. Storage should be kept in a clean, dry place away from direct sunlight until use.
Frequently asked questions
What are the key dimensions of this surgical face mask and how does the ear-loop design benefit the user?
The mask measures 17.5 cm × 9.5 cm, providing a standard fit for most clinical applications. The ear-loop design ensures secure positioning without the need for ties, reducing adjustment time during procedures and improving comfort for prolonged wear. This is particularly useful in surgical environments where stability and ease of use are critical.
Is this mask intended for reuse, or is it designed for single-use only? How does that affect its use in clinical settings?
This mask is explicitly designed for single-use only, as stated in the description. The disposable, non-woven fabric filter layer is engineered to provide barrier protection during one procedure, minimizing the risk of cross-contamination between patients or healthcare workers. Single-use ensures hygiene compliance and reduces the need for reprocessing, which is essential in sterile surgical environments.
How should this mask be stored before use, and what precautions should be taken to maintain its sterility?
The mask is supplied sterile in individual packaging, so it should be stored in a clean, dry place away from direct sunlight until use. Keeping it sealed and protected from moisture or dust ensures sterility is preserved. Avoid storing it in areas with extreme temperatures or humidity, as these conditions could compromise the integrity of the packaging or the mask’s barrier properties.
What regulatory pathways does this mask follow, and how does that ensure its suitability for surgical use?
This mask has undergone FDA 510(k) clearance (K220749) under the Traditional pathway, with a decision classified as *Substantially Equivalent* to predicate devices, and it also complies with EU MDR requirements. These clearances confirm that the device meets established safety and performance standards for surgical face masks, ensuring it is suitable for use in clinical settings where infection control is paramount.
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
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K220749 | Class II | Active |
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Manufacturer
- Manufacturer
- Unimax Medical Products Co., Ltd.
Sources (9)
- FDA 510(k) K220749 24 fields · synced Oct 7, 2026
- EUDAMED 579c2bbe-2218-4518-b32f-1cde947eb7a2 61 fields · synced Jul 8, 2026
- EUDAMED 0bfb4d7a-8e0d-4854-86c3-b218c72796c3 61 fields · synced Jul 9, 2026
- EUDAMED fd0499a8-4202-477a-8d9e-16305fca4d85 61 fields · synced Jul 9, 2026
- EUDAMED be31b5d5-7cc0-4018-b7e5-6e5fca58fc8d 61 fields · synced Jul 9, 2026
- EUDAMED ba91f07f-338c-4e0d-9125-076f05ce45b1 61 fields · synced Jul 13, 2026
- EUDAMED ed735b80-964e-47e4-8133-eea54b103472 61 fields · synced Jul 17, 2026
- EUDAMED b312cf46-4c06-41d2-882b-57297061629a 61 fields · synced Jul 25, 2026
- EUDAMED b7b42b32-46dc-471f-9011-176e0c258478 61 fields · synced Oct 5, 2026