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Inovel Health Care N95 Particulate Respirators & Surgical Masks

by Inovel, LLC

510(k) K061859

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 NumberK061859 Date12 Jul 2006ClearedStatusActive

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  • Withdrawn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, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Inovel Health Care N95 Particulate Respirators and Surgical Masks are particulate respirators and surgical masks designed to provide respiratory protection and barrier protection in healthcare settings. These devices incorporate highly efficient filter media with 95% efficiency or better against aerosols with a count median diameter of 0.055 to 0.095 microns, meeting CDC guidelines for TB exposure control.

These devices are intended to be worn by healthcare personnel during surgical procedures to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. They are supplied as non-sterile, single-use devices and have received FDA 510(k) clearance under K061859, with product code MSH and device class II.

Other devices from Inovel, LLC

Questions

AI-generated answers, 6 Oct 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 Inovel Health Care N95 Particulate Respirator and Surgical Mask used for?

    It is designed to provide respiratory protection against airborne particulates and barrier protection against microorganisms and body fluids during surgical procedures, protecting both healthcare personnel and patients.

  • How is the Inovel Health Care N95 supplied and is it sterile or reusable?

    The device is supplied as a non-sterile, single-use product intended for one-time wear during healthcare procedures and should be discarded after use to maintain protection integrity.

  • What regulatory clearance does the Inovel Health Care N95 have and what is its product code?

    It has received FDA 510(k) clearance under submission K061859 and is classified under product code MSH as a Class II device.