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Aurelia Surgical Mask ASTM Level-3 (2130)

by Supermax Healthcare Canada-Supermax Medical

510(k) K242502

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK242502 Date12 Nov 2024ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Overview

AI-generated summary, 19 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 Aurelia Surgical Mask ASTM Level 3 (2130) is a three-ply surgical mask designed to minimize airborne contamination from inhaled and exhaled microorganisms. It meets ASTM Level 3 standards for fluid resistance and particulate filtration, providing protection against blood and body fluids while ensuring breathability for prolonged wear.

This mask is supplied as a single-use, non-latex disposable item with an enclosed aluminum nosepiece for improved fit and comfort. It is intended for use in clinical and non-clinical settings, including dental, veterinary, and pharmaceutical environments. The device carries FDA 510(k) clearance under K242502 and is manufactured in Canada.

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