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Disposable Surgical Mask (FXX)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K202126

by Shenzhen Peninsula Medical Co., Ltd.

Identifiers

510(k) Number
K202126 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 Disposable Surgical Mask, classified under FDA product code FXX. It is designed to provide a barrier against droplets, splashes, and large-particle airborne contaminants, ensuring protection for both patients and healthcare providers during surgical and medical procedures. The mask is intended for single-use to maintain sterility and hygiene standards in clinical environments. Its construction adheres to regulatory standards for fluid resistance and filtration efficiency, as required for surgical settings.

The mask is supplied as a disposable, single-use item, intended for one-time use per patient encounter. It is not intended for reuse or sterilisation and must be discarded after use to prevent cross-contamination. The device is regulated under FDA 510(k) clearance (K202126), with a Traditional review pathway and classified as Substantially Equivalent to predicate devices. Storage should follow manufacturer guidelines to preserve integrity, and no specific MRI safety considerations apply due to its non-metallic, non-electronic design.

Frequently asked questions

What is the primary purpose of this disposable surgical mask in clinical settings?

This disposable surgical mask is designed to act as a barrier against droplets, splashes, and large-particle airborne contaminants, protecting both patients and healthcare providers during surgical and medical procedures. Its fluid resistance and filtration efficiency meet regulatory standards for surgical environments, ensuring hygiene and safety during one-time use per patient encounter.

Is this mask intended for reuse, or is it strictly single-use?

The mask is explicitly intended for single-use only to maintain sterility and hygiene. Reuse or sterilization is not recommended, as it could compromise the mask’s protective integrity and increase the risk of cross-contamination in clinical settings.

How should this mask be stored to ensure it remains effective?

Storage should follow the manufacturer’s guidelines to preserve the mask’s integrity. While no specific storage conditions are detailed in the data, typical best practices for disposable surgical masks include keeping them in a clean, dry environment away from direct sunlight or extreme temperatures until use.

What regulatory pathway was used for FDA clearance, and what does that mean for its safety and equivalence?

This mask received FDA clearance through the 510(k) Traditional review pathway under clearance number K202126, with a decision of Substantially Equivalent (SESE) to predicate devices. This means the FDA determined it has the same intended use and technological characteristics as legally marketed devices, ensuring it meets safety and effectiveness standards for its intended purpose.

Are there any special considerations for using this mask in environments with MRI equipment?

No special MRI safety considerations are required for this mask, as it is made of non-metallic, non-electronic materials. This means it can be safely used in proximity to MRI machines without interference or risk.

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: Disposable Surgical Mask (K202126) - FDA 510 (k), Shenzhen Peninsula Medical Co., Ltd. FDA Filings - FDA.report, K202126 - Mask, Surgical FDA 510 (k) APPLICATION FOR Shenzhen Peninsula ..., PDF Cassie L - Food and Drug Administration

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Peninsula Medical Co., Ltd.

Sources (1)

  • FDA 510(k) K202126 24 fields · synced Sep 20, 2026