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Willson One-Fit Flat-Fold Healthcare Particulate Respirator and Surgical Mask, Models HC-NB095F and HC-NB295F

by Survivair Respirators, LLC

510(k) K070782

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 NumberK070782 Date11 Apr 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  • Withdrawn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, 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 Willson One-Fit Flat-Fold Healthcare Particulate Respirator and Surgical Mask is a NIOSH-approved N95 single-use respirator designed for healthcare personnel during medical/surgical procedures. It protects both the wearer and patient by guarding against the spatter of blood and other potentially infectious materials.

This device is supplied as a single-use product and is not intended for reuse. It is authorized under FDA 510K clearance with K070782 and product code MSH. The models HC-NB095F and HC-NB295F are available in specific sizes as manufactured by Survivair Respirators, LLC.

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 Willson One-Fit Flat-Fold Respirator used for?

    The Willson One-Fit Flat-Fold Healthcare Particulate Respirator and Surgical Mask is designed for healthcare personnel during medical/surgical procedures to protect both the wearer and patient by guarding against the spatter of blood and other potentially infectious materials.

  • Is this respirator single-use or reusable?

    This device is supplied as a single-use product and is not intended for reuse. It should be discarded after each use to maintain its protective capabilities and prevent cross-contamination.

  • What sizes and models are available for the Willson One-Fit Respirator?

    The Willson One-Fit Flat-Fold Healthcare Particulate Respirator is available in two models: HC-NB095F and HC-NB295F, each manufactured in specific sizes by Survivair Respirators, LLC to accommodate different facial dimensions.

  • What regulatory authorization does this respirator have?

    The Willson One-Fit Flat-Fold Respirator is authorized under FDA 510K clearance with K070782 and product code MSH, indicating it is substantially equivalent to predicate devices for its intended use.