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Non-Sterile Surgical Mask

by A.R. Medicom, Inc. 510(k)

Active United States

510(k) K051291

Overview

This device is a surgical mask, a barrier designed to reduce the risk of contamination from the wearer to patients or environments during medical procedures. It conforms to the FDA’s classification as a Mask, Surgical under product code FXX, intended for use in general and plastic surgery settings.

The mask is non-sterile and supplied as a single-use item, requiring no reprocessing. It is regulated under FDA 510(k) clearance (K051291) with a Substantially Equivalent (SESE) determination, adhering to regulatory standards for infection control in healthcare. No MRI safety or sterility claims are associated with this product.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

Recall ongoing. 3 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK051291 Date20 Sep 2005ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

5 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-1148-2024 FDA Class II initiated 21 Dec 2023
    • Ongoing Z-1147-2024 FDA Class II initiated 21 Dec 2023
    • Ongoing Z-1146-2024 FDA Class II initiated 21 Dec 2023

    Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.

  • 2 recalls, same reason

    • Terminated Z-0494-2020 FDA Class II initiated 11 Oct 2019
    • Terminated Z-0495-2020 FDA Class II initiated 11 Oct 2019

    Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The two masks are visually indistinguishable, causing the risk of using a mask with a lower protection level than intended.

Specification

510(k)

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

Other devices from A.R. Medicom, Inc.

Questions

  • What types of medical procedures is this surgical mask designed to protect against contamination during?

    This surgical mask is designed to act as a barrier to reduce contamination risk from the wearer to patients or the environment during general and plastic surgery procedures. It is classified under FDA product code FXX for surgical masks, ensuring it meets regulatory standards for infection control in those specific surgical settings.

  • Is this mask intended for reuse, or is it meant to be used only once?

    This mask is explicitly labeled as a single-use item and requires no reprocessing. The manufacturer advises discarding it after one use to maintain infection control standards, as reuse could compromise its barrier properties and increase contamination risks.

  • How should I store this mask before use, and does it come in a sterile package?

    The mask is non-sterile, so it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. It is supplied as a single-use item, so no additional sterilization is required before use—simply open the package immediately before donning to minimize exposure to contaminants.

  • What regulatory pathway does this mask follow, and how does that affect its use in healthcare settings?

    This mask follows the FDA 510(k) clearance pathway, specifically with a Substantially Equivalent (SESE) determination under clearance number K051291. This means it meets FDA standards for surgical masks (product code FXX) and is approved for use in general and plastic surgery settings to reduce contamination risk from the wearer.