3-Ply Disposable Medical Mask
by Wealth Lead Industrial Limited
510(k) K223045
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK223045 | Date7 Dec 2022 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FXX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4040
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The 3-Ply Disposable Medical Mask is a barrier device classified under the FDA’s product code FXX, designed to protect healthcare personnel and patients from airborne contaminants. Constructed with three layers of non-woven fabric, it provides filtration and fluid resistance to reduce the transmission of respiratory droplets and pathogens. Its disposable design ensures single-use compliance with infection control protocols, making it suitable for general hospital settings and surgical environments. The mask adheres to regulatory standards for medical-grade protection without requiring sterilisation between uses.
This device is supplied as a single-use item, intended for one-time application before disposal. It is not intended for reuse or sterilisation and must be discarded after use to maintain hygiene. The mask is non-sterile by design and does not require MRI compatibility testing. Sizes are not specified in the regulatory submission, but typical medical masks follow standard dimensions for adult use. Authorised under FDA 510(k) clearance K223045 as substantially equivalent to predicate devices, it complies with the General, Plastic Surgery advisory committee classification and is distributed by Wealth Lead Industrial Limited, Hong Kong.
Questions
AI-generated answers, 1 Oct 2026
What is the 3-Ply Disposable Medical Mask designed for?
This mask is a barrier device intended to protect healthcare personnel and patients from airborne contaminants, including respiratory droplets and pathogens. Its three-layer non-woven fabric construction provides filtration and fluid resistance, making it suitable for general hospital and surgical environments where infection control is critical.
Is the mask reusable or single-use?
The mask is explicitly designed for single-use only. Its disposable nature aligns with infection control protocols, ensuring hygiene by preventing reuse or sterilization between applications. Discarding it after use is mandatory to maintain regulatory compliance.
Does this mask require sterilization before use?
No, the mask is non-sterile by design and does not require sterilization before use. It is supplied ready-to-wear and must be discarded immediately after use to avoid contamination. This aligns with its classification as a single-use barrier device.
What are the typical dimensions or sizes of this mask?
While the regulatory submission does not specify exact dimensions, this mask follows standard adult-sized medical mask measurements. It is designed to fit typical adult facial contours for optimal coverage and protection during use.
How is the mask supplied, and what storage considerations apply?
The mask is supplied individually packaged for single-use, ensuring sterility is not required. Storage should be in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its integrity. Avoid storing in humid or contaminated areas to prevent degradation of the material.