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Surgical Face Mask, Tie-On, Ear-Loop (K063043)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K063043

by Modern Healthcare Corp.

Identifiers

510(k) Number
K063043 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 Surgical Face Mask designed to provide barrier protection for healthcare personnel and patients during surgical and medical procedures. It features a three-ply construction with an inner and outer layer of spunbonded polypropylene and a middle layer of melt-blown polypropylene filter material, ensuring fluid resistance and filtration efficiency. The mask includes a malleable aluminum nosepiece for a customizable fit and is available in two configurations: tie-on or ear-loop.

The mask is intended for single-use in clinical settings such as operating rooms, examination rooms, and other areas requiring sterile barrier protection. Supplied in sterile packaging, it adheres to FDA 510(k) clearance (K063043) under the Medical Device Regulation 878.4040, classified under the product code FXX. No third-party certification is indicated, and its design complies with the Medical Device Directive (MDD) standards.

Frequently asked questions

What are the key differences between the tie-on and ear-loop configurations of this surgical face mask, and which one should I choose for my clinical setting?

The mask is available in two configurations: tie-on, which uses adjustable straps tied behind the head for a secure fit, and ear-loop, which features elastic loops that go over the ears for convenience. The choice depends on patient comfort and ease of use—tie-on may be preferred for prolonged procedures or when adjusting the fit frequently, while ear-loop offers quicker application and removal, ideal for high-turnover settings like outpatient clinics or emergency rooms.

Is this mask suitable for reuse, or is it designed for single-use only? How does that affect its sterile packaging?

This mask is explicitly designed for single-use only, as indicated in the description. Its sterile packaging ensures it remains uncontaminated until first use, which is critical for maintaining infection control standards in surgical and medical procedures. Reuse is not recommended, as it could compromise the mask’s barrier protection and filtration integrity.

What materials make up the mask’s three-ply construction, and how do they contribute to its performance?

The mask features a three-ply design: an inner and outer layer of spunbonded polypropylene for durability and fluid resistance, paired with a melt-blown polypropylene filter layer in the middle. This combination enhances filtration efficiency while maintaining breathability, making it effective for protecting against airborne particles and splashes during procedures.

How should I store this mask to ensure it remains effective until use, and are there any specific environmental conditions to consider?

The mask should be stored in its original sterile packaging to preserve sterility and prevent contamination. Keep it in a cool, dry place away from direct sunlight or extreme temperatures, as these conditions could degrade the material over time. Avoid storing it in areas with high humidity or chemical exposure, which may compromise the mask’s integrity before use.

What does the FDA’s 510(k) clearance (K063043) under product code FXX mean for clinicians using this mask in operating rooms?

The FDA’s 510(k) clearance (K063043) under product code FXX (Surgical Dressings and Supplies) confirms that this mask meets regulatory standards for safety and effectiveness as a barrier protection device in surgical settings. Clinicians can rely on it for sterile procedures, knowing it has undergone evaluation for substantial equivalence to predicate devices, though it does not imply approval for specific clinical indications beyond its intended use.

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: Amazon.com: Surgical Mask Ear Loop, SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP (K063043 ... - fda ..., SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP 510(k)… - FDA.report, Amazon.com: Surgical Mask Tie Back

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Modern Healthcare Corp.

Sources (2)

  • FDA 510(k) K063043 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026