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INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK - 3001N95-S

by Inovel, LLC

510(k) K042267

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK042267 Date30 Sep 2004ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1576-2009 FDA Unclassified (pre-2012) initiated 23 Jul 2008

    Display boxes labeled as FRN95-MLEZ, Medium/Large Size Respirators were inadvertently mixed with Display Boxes labeled for FRN95-SEZ Small Size Respirators.

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  • Withdrawn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
Models / Variants
3001N95-S
Device Class
Class II
Regulation
21 CFR Part 878.4040
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Inovel Health Care N95 Particulate Respirator and Surgical Mask is a respiratory protective device designed to filter airborne particles. It functions as both a respirator and a surgical mask to provide protection for the wearer.

This device is available in four sizes: 3001N95-S, 3002N95-M, 3003N95-L, and 3004N95-LP. It has received FDA 510k clearance under K042267.

Other devices from Inovel, LLC

Questions

AI-generated answers, 23 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 function of the Inovel N95 respirator?

    This device is designed to serve a dual purpose as both a respiratory protective device and a surgical mask. It functions by filtering airborne particles to provide protection for the wearer during clinical or healthcare-related activities.

  • What size options are available for this respirator?

    The device is manufactured in four specific sizes to accommodate different users: 3001N95-S (Small), 3002N95-M (Medium), 3003N95-L (Large), and 3004N95-LP (Large Profile).

  • Has this device undergone a regulatory review process?

    Yes, the Inovel N95 Particulate Respirator and Surgical Mask has received FDA 510k clearance under submission number K042267. This indicates that the device was found to be substantially equivalent to legally marketed predicate devices.