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Willson One-Fit Healthcare Particle Respirator And Surgical Mask, HC-NB095

by Survivair, Inc.

510(k) K070139

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 NumberK070139 Date2 Mar 2007ClearedStatusActive

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  • Withdrawn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
MSH
Device Class
Class II
Regulation
21 CFR Part 878.4040
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Willson One-Fit Healthcare Particle Respirator And Surgical Mask, Hc-Nb095 is a respirator and surgical mask designed to protect the wearer and the patient from potentially infectious materials. It is a single-use device.

The device is supplied as a single-use respirator and surgical mask, and it has been authorized with an FDA 510K clearance. The device has a product code of MSH and is available in the size HC-NB095.

Other devices from Survivair, Inc.

Questions

AI-generated answers, 27 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 Willson One-Fit Respirator Mask used for?

    The Willson One-Fit Respirator Mask is designed to protect the wearer and the patient from potentially infectious materials, making it suitable for use in healthcare settings.

  • Is the Willson One-Fit Respirator Mask reusable?

    No, the Willson One-Fit Respirator Mask is a single-use device, intended to be discarded after one use to maintain its effectiveness and prevent the risk of infection.

  • What size is the Willson One-Fit Respirator Mask available in?

    The Willson One-Fit Respirator Mask is available in the size HC-NB095, ensuring a proper fit for the wearer.