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Aurelia Surgical Mask ASTM Level 1 - Aurelia Surgical Mask ASTM Level 1

by Supermax Healthcare Canada-Supermax Medical

510(k) K231005

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 NumberK231005 Date5 Dec 2023ClearedStatusActive

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  • Withdrawn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
Models / Variants
Aurelia Surgical Mask ASTM Level 1
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 is a three-layer, disposable face mask designed to provide barrier protection for healthcare personnel and patients during surgical procedures. Constructed with an inner and outer spun-bonded polypropylene layer and a middle melt-blown polypropylene filtration layer, it meets ASTM Level 1 and Level 2 filtration standards for surgical environments. The mask features polyurethane/nylon ear loops and a 3mm aluminum flat wire nose clip to ensure a secure fit.

This single-use, non-sterile device is intended for clinical settings and is supplied in sterile packaging as required for surgical use. It is classified under FDA product code FXX and has received a Substantially Equivalent (SESE) determination via 510(k) clearance (K231005). Compliance with ASTM standards ensures appropriate filtration performance for its designated use.

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