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MASC Surgical Mask

by Mid-America Safety Corp.

510(k) K211984

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 NumberK211984 Date25 Jul 2021ClearedStatusActive

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  • Withdrawn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
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 MASC Surgical Mask is a disposable barrier device designed to protect healthcare professionals and patients from airborne contaminants during surgical and medical procedures. Classified under product code FXX, it meets regulatory standards for fluid resistance and filtration efficiency, ensuring a sterile field and reducing infection risk in clinical settings.

Supplied as a single-use item, the mask is cleared by the FDA under 510(k) number K211984 and is intended for use in sterile environments such as operating rooms and procedural areas. Manufactured by Mid-America Safety Corp. in Elk Grove Village, IL, it adheres to traditional review pathways and third-party testing requirements. No additional regulatory markings beyond the FDA clearance are specified.

Other devices from Mid-America Safety Corp

Questions

AI-generated answers, 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.

  • What types of clinical environments is the MASC Surgical Mask intended for use in?

    The MASC Surgical Mask is designed for sterile environments such as operating rooms and procedural areas where protecting both healthcare professionals and patients from airborne contaminants is critical. Its fluid resistance and filtration efficiency make it suitable for surgical and medical procedures where maintaining a sterile field is essential.

  • Is the MASC Surgical Mask reusable or single-use, and how should it be handled after use?

    The MASC Surgical Mask is explicitly labeled as a disposable device, meaning it is intended for single-use only. After use, it should be discarded in accordance with facility protocols for medical waste to prevent contamination and ensure infection control.

  • What regulatory pathway was followed for FDA clearance of the MASC Surgical Mask, and what does this mean for its safety and performance?

    The MASC Surgical Mask was cleared through the traditional 510(k) review pathway under FDA clearance number K211984, with a decision of Substantially Equivalent (SE) to a predicate device. This means the FDA determined it meets established safety and performance standards for surgical masks, including fluid resistance and filtration efficiency, while adhering to third-party testing requirements.

  • How is the MASC Surgical Mask manufactured, and where can I find more information about the manufacturer?

    The MASC Surgical Mask is manufactured by Mid-America Safety Corp. in Elk Grove Village, IL. For additional details, including technical specifications or support, you can contact the manufacturer directly at their address (800 Greenleaf Ave., Elk Grove Village, IL 60007) or via their listed contact, Yunxiang (Phil) Fan.