Disposable Medical Mask
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K210150 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)
This device is a Disposable Medical Mask, classified under the FDA’s product code FXX. It is designed to provide a barrier against airborne particles, droplets, and splashes, offering protection for both healthcare workers and patients in clinical settings. The mask is intended for single-use and conforms to standards for medical-grade filtration and breathability.
The mask is supplied as a sterile, disposable item, intended for use in healthcare environments where infection control is critical. It is regulated under the FDA’s 510(k) clearance process, with a decision dated June 2, 2021, confirming substantial equivalence to predicate devices. No additional sterilization or reprocessing is required, and it must be discarded after use to maintain hygiene standards. Compliance with MDR (Medical Device Regulation) is also noted.
Frequently asked questions
What is the primary purpose of this disposable medical mask in clinical settings?
This disposable medical mask is designed to act as a barrier against airborne particles, droplets, and splashes, protecting both healthcare workers and patients from contamination in clinical environments. Its filtration and breathability meet medical-grade standards, making it suitable for infection control where single-use hygiene is critical.
Is this mask intended for reuse, or is it meant to be discarded after a single use?
The mask is explicitly intended for single-use only and must be discarded after use to maintain hygiene standards. No additional sterilization or reprocessing is required or recommended, as reuse could compromise its protective integrity.
How is this mask supplied, and does it require any special handling before use?
The mask is supplied as a sterile, disposable item, ready for immediate use in healthcare settings. Since it’s pre-sterilized, no further sterilization steps are needed—simply remove it from packaging and apply it to the user’s face.
What regulatory pathways does this mask follow, and how was its safety and performance validated?
This mask follows the FDA’s 510(k) clearance process, with a decision dated June 2, 2021, confirming it is substantially equivalent to predicate devices under product code FXX. It also complies with the EU’s Medical Device Regulation (MDR), ensuring its design meets both U.S. and European standards for medical-grade filtration and protection.
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. Sources consulted: Made-in-China.com - Hubei Wanli Protective Products Co., Ltd., Disposable Coverall Manufacturer | Hbwanli, Hubei Wanli Protective Products Co.,Ltd.
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 | K210150 | 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) K210150 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 29, 2026