Skip to content

Heartland Health Surgical Mask (K212366)

by Heartland Health Products

510(k) K212366

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 · Abbreviated NumberK212366 Date19 Feb 2022ClearedStatusActive

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  • Withdrawn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)

Full name
Heartland Health Surgical Mask
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 Heartland Health Surgical Mask (K212366) is a three-layer disposable face mask designed for surgical use. It features a flat-pleated construction with a spunbond polypropylene outer layer, a polypropylene filter layer, and a spunbond polypropylene inner layer, providing barrier protection against airborne particles and splashes.

This single-use, non-sterile device is intended for healthcare settings and includes a nose wire and elastic headband with Lycra chin elastic to ensure a secure fit. Supplied in a sterile or non-sterile form as specified, it adheres to FDA 510(k) clearance under product code FXX, with a decision classification of Substantially Equivalent. Storage and handling follow standard medical device protocols for disposable protective barriers.