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Fluid Resistant Mask

by American Threshold Healthcare

510(k) K955556

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 NumberK955556 Date25 Apr 1996ClearedStatusActive

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  • Withdrawn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, 22 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 Fluid Resistant Mask is a medical device designed to provide a barrier against fluids. It is intended to protect the wearer from exposure to liquid splashes and droplets in clinical settings.

This device is supplied by American Threshold Healthcare and has received FDA 510(k) clearance under K955556. It is classified as an FDA class 2 device.

Other devices from American Threshold Healthcare

Questions

AI-generated answers, 22 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 is the primary purpose of the Fluid Resistant Mask?

    This medical device is designed to act as a barrier for the wearer, specifically intended to provide protection against exposure to liquid splashes and droplets encountered within clinical settings.

  • What is the regulatory status of this mask?

    The Fluid Resistant Mask has received FDA 510(k) clearance under K955556. It is classified as an FDA class 2 medical device, having been determined to be substantially equivalent to existing devices.

  • Who is the manufacturer of this device?

    This mask is supplied by American Threshold Healthcare, located in Enka, North Carolina. They are the applicant of record for the FDA 510(k) clearance associated with this product.