Dukal Surgical Face Mask Tie-On, Model 1530 +2 more models
FDA 510(k)Class II (US FDA 510(k))
by Dukal Corp.
Identifiers
- 510(k) Number
- K061864 FDA 510(k)
- FDA Product Code
- FXX FDA 510(k)
- Models / Variants
- Dukal Surgical Face Mask Tie-On, Model 1530 FDA 510(k)Ear Loop, Model 1540 FDA 510(k)With Shield, Model 1560 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 Dukal Surgical Face Mask is a 3-ply protective barrier for the nose and mouth. It is available in three models: tie-on (Model 1530), ear loop (Model 1540), and with shield (Model 1560). The construction includes inner and outer layers of spun-bond polypropylene or medical grade tissue with a middle layer of melt-blown polypropylene filter media.
This device is supplied as a single-use item and is intended for surgical procedures. It has received FDA 510(k) clearance with K number K061864 and is classified under product code FXX. The device is not indicated for MRI use and should be stored according to manufacturer instructions.
Frequently asked questions
What is the Dukal Surgical Face Mask used for?
The Dukal Surgical Face Mask is a 3-ply protective barrier for the nose and mouth, intended for use during surgical procedures. It is designed to help prevent the transmission of contaminants between the wearer and the surgical environment.
What models are available for the Dukal Surgical Face Mask?
The Dukal Surgical Face Mask is available in three models: tie-on (Model 1530), ear loop (Model 1540), and with shield (Model 1560). Each model offers the same 3-ply protective barrier but with different attachment methods to suit various preferences and requirements.
Is the Dukal Surgical Face Mask reusable or single-use?
The Dukal Surgical Face Mask is supplied as a single-use item and should not be reused. It is designed for one-time use during surgical procedures to maintain optimal protective qualities and prevent cross-contamination.
What is the regulatory status of the Dukal Surgical Face Mask?
The Dukal Surgical Face Mask has received FDA 510(k) clearance with K number K061864 and is classified under product code FXX. This indicates that the device has been determined to be substantially equivalent to predicate devices already on the market.
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: Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; With ..., PDF DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR… - FDA.report, Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; With ..., Surgical Masks - dukal.com, Dukal Surgical Face Mask Tie, Ear Loop, With Shield Yellow & White ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K061864 | Class II | Active |
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Manufacturer
- Manufacturer
- Dukal Corp.
Sources (1)
- FDA 510(k) K061864 24 fields · synced Oct 1, 2026