Skip to content

ECOMA Level 2 Disposable Surgical Mask with Ear Loops

by Xianning Eco Medical Articles Co., Ltd.

510(k) K210698

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K210698↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK210698 Date19 Aug 2021ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
FXX
Device Class
Class II
Regulation
21 CFR Part 878.4040
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ECOMA Level 2 Disposable Surgical Mask with Ear Loops is a disposable surgical mask designed to provide barrier protection against liquid splashes and airborne particles in clinical settings. Classified under the FDA’s product code FXX, it adheres to Level 2 filtration standards, ensuring reduced transmission of infectious agents during surgical and medical procedures.

This mask is intended for single-use in operating rooms, dental clinics, and other sterile environments where infection control is critical. Supplied in sterile packaging, it features ear loops for secure, hands-free positioning and is compliant with FDA 510(k) clearance (K210698) and EU MDR requirements. Storage should follow manufacturer guidelines to maintain sterility and integrity until use.

Other devices from Xianning Eco Medical Articles Co., Ltd.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical settings is this mask designed for and what level of protection does it provide?

    The ECOMA Level 2 Disposable Surgical Mask with Ear Loops is specifically designed for use in operating rooms, dental clinics, and other sterile environments where infection control is critical. It provides barrier protection against liquid splashes and airborne particles, adhering to Level 2 filtration standards to help reduce the transmission of infectious agents during surgical and medical procedures.

  • Is this mask intended for reuse or single-use, and how is it packaged?

    This mask is explicitly designed for single-use only to ensure hygiene and infection control. It is supplied in sterile packaging, which maintains its integrity until the time of use, making it safe for one-time clinical application.

  • How is the mask secured on the user, and what practical advantages does this design offer?

    The mask features ear loops, allowing for secure, hands-free positioning. This design eliminates the need to touch the mask with bare hands during application, reducing the risk of contamination and making it more convenient for healthcare providers to don the mask quickly in sterile environments.

  • What regulatory approvals does this mask hold, and how does that affect its use?

    The ECOMA Level 2 mask holds FDA 510(k) clearance (K210698) under product code FXX, confirming it meets U.S. standards for Level 2 filtration and barrier protection. It also complies with EU MDR requirements, ensuring its suitability for use in both FDA-regulated and EU markets. These approvals validate its safety and performance for single-use in clinical settings where infection control is mandatory.

  • How should I store this mask to ensure it remains sterile and functional until use?

    To maintain sterility and integrity, storage should follow the manufacturer’s guidelines—typically, the mask should remain in its original, unopened sterile packaging until ready for use. Avoid exposure to moisture, extreme temperatures, or physical damage, as these factors could compromise its protective properties or filtration effectiveness.