Disposable Medical Mask
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K214085 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)
The Disposable Medical Mask is a single-use barrier device designed to protect the wearer’s respiratory tract from airborne contaminants, splashes, and droplets. Classified under the nomenclature for protective masks, it is intended to reduce exposure to infectious agents and particulate matter in clinical and healthcare settings.
Supplied in sterile packaging, this mask is intended for one-time use and must not be reused. It complies with FDA 510(k) clearance under the Traditional pathway (K214085) and EU MDR requirements. The device is non-reusable, non-sterile after opening, and has no MRI safety considerations. Storage should follow manufacturer guidelines to maintain integrity until use.
Frequently asked questions
What is the primary purpose of this disposable medical mask in clinical settings?
This disposable medical mask is designed as a single-use barrier device to protect the wearer’s respiratory tract from airborne contaminants, splashes, and droplets. It helps reduce exposure to infectious agents and particulate matter, making it suitable for use in clinical and healthcare environments where contamination risks are present.
Is this mask reusable, and what happens to its sterility after opening?
No, this mask is explicitly intended for one-time use only and must not be reused. Once the sterile packaging is opened, the mask is no longer considered sterile, so it should be discarded immediately after use to maintain infection control standards.
How should I store this mask before use to ensure it remains effective?
Storage should follow the manufacturer’s guidelines to preserve the mask’s integrity until use. Since it is supplied in sterile packaging, avoid exposing it to moisture, extreme temperatures, or physical damage that could compromise its protective properties or sterility.
What regulatory pathways does this mask follow, and how does that affect its use?
This mask is cleared under the FDA 510(k) Traditional pathway (K214085) and complies with EU MDR requirements. These pathways confirm its equivalence to existing devices and ensure it meets regulatory standards for safety and performance in healthcare settings, but they do not alter its intended single-use purpose or clinical application.
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 | K214085 | Class II | Active |
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Manufacturer
- Manufacturer
- Hubei Wanli Protective Products Co., Ltd
- FDA Applicant
- Hubei Wanli Protective Products Co., Ltd.
Sources (2)
- FDA 510(k) K214085 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026