Moldex N95 Particulate Respirators and Surgical Masks
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K062663 FDA 510(k)
- FDA Product Code
- MSH 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 Moldex N95 Particulate Respirator and Surgical Mask is a disposable device designed to provide respiratory protection and bacterial filtration. It functions as both a surgical mask and a particulate respirator, offering protection against laser plumes of surgical smoke and meeting CDC guidelines for tuberculosis exposure control in healthcare facilities.
This device features a Dura-Mesh shell designed to resist collapse in heat and humidity and includes securely attached straps. It is supplied as a single-use product and has received FDA 510k clearance. The respirator is available in various sizes, including extra small, and is manufactured by Moldex/Metric, Inc.
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: N95 Healthcare Respirators & Surgical Masks - Moldex, Moldex 1510 N95 Disposable Healthcare Particulate Respirator & Surgical ..., Moldex N95 Disposable Healthcare Particulate Respirator & Surgical Mask ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K062663 | Class II | Active |
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Manufacturer
- Manufacturer
- Moldex/Metric, Inc.
Sources (1)
- FDA 510(k) K062663 24 fields · synced Oct 6, 2026