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Surgical Face Mask

FDA 510(k)

Class II (US FDA 510(k))

510(k) K881910

by Louis M. Gerson Co., Inc.

Identifiers

510(k) Number
K881910 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, classified under FDA product code FXX and regulatory category 878.4040. It is designed to provide a barrier against airborne contaminants and splashes during surgical and medical procedures, helping to reduce the risk of infection for both patients and healthcare providers. The mask is intended for single-use in controlled clinical environments where sterility and protection are critical.

The Surgical Face Mask is supplied as a sterile, disposable item and is regulated under FDA 510(k) clearance (K881910) with a Substantially Equivalent determination by the Surgical and Urological Devices (SU) Advisory Committee. It is intended for use in general and plastic surgery settings, adhering to standard surgical hygiene protocols. No additional regulatory markings or MRI safety classifications are specified.

Frequently asked questions

What is the Gerson Surgical Face Mask designed to protect against?

The Gerson Surgical Face Mask is engineered as a barrier against airborne contaminants and splashes, reducing infection risks during surgical and medical procedures. Its design aligns with FDA product code FXX and regulatory category 878.4040, ensuring protection for both patients and healthcare providers in sterile environments.

Is this mask intended for reuse or single-use?

This mask is explicitly supplied as a single-use item. It is sterile upon packaging and intended for controlled clinical settings where sterility and protection are critical, preventing cross-contamination between uses.

What regulatory clearance does the Gerson Surgical Face Mask hold?

The mask holds FDA 510(k) clearance (K881910) with a *Substantially Equivalent* determination by the Surgical and Urological Devices (SU) Advisory Committee. This clearance confirms compliance with FDA standards for surgical face masks, including performance and safety requirements.

Where is this mask approved for use?

The mask is approved for use in general and plastic surgery settings. Its design adheres to standard surgical hygiene protocols, ensuring compatibility with controlled clinical environments where infection control is paramount.

How should the mask be stored before use?

The mask is supplied in a sterile, sealed package. Storage should maintain the original packaging until use to preserve sterility. Avoid exposure to moisture, extreme temperatures, or direct sunlight, as these conditions could compromise the mask’s integrity or sterility.

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: LABELING CHANGE TO SURGICAL FACE MASK - Innolitics, Labeling Change to Surgical Face Mask - Beudamed, LABELING CHANGE TO SURGICAL FACE MASK 510(k) K881910 - FDA.report, Louis M. Gerson Co., Inc. FDA 510 (k) Products (1980-2006)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Louis M. Gerson Co., Inc.

Sources (1)

  • FDA 510(k) K881910 24 fields · synced Oct 1, 2026