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Inovel Health Care N95 Particulate Respirators and Surgical Masks, Models MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A

by Inovel, LLC

510(k) K063747

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 NumberK063747 Date12 Jan 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  • Withdrawn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
Models / Variants
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.

This device is a respirator and surgical mask designed for healthcare use. It is intended to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material during surgical procedures and to meet CDC Guidelines for TB Exposure Control within healthcare facilities.

The device is supplied as non-sterile, single-use respirators and surgical masks in multiple sizes: MFRN95-S, MFRN95-XS, MFRN95-ML, and MFRN95-A. It received FDA 510(k) clearance (K063747) on January 12, 2007, and is classified under product code MSH for use in general and plastic surgery settings.

Other devices from Inovel, LLC

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 Inovel N95 respirator and surgical mask used for?

    It is designed to protect both patients and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material during surgical procedures and to meet CDC Guidelines for TB Exposure Control in healthcare facilities.

  • How is the Inovel N95 respirator and surgical mask supplied?

    The device is supplied as non-sterile, single-use respirators and surgical masks in multiple sizes: MFRN95-S, MFRN95-XS, MFRN95-ML, and MFRN95-A.

  • Are the Inovel N95 respirator and surgical masks reusable?

    No, the devices are designated for single-use only and must be discarded after each use to maintain effectiveness and prevent cross-contamination.

  • What regulatory clearance does the Inovel N95 respirator and surgical mask have?

    It received FDA 510(k) clearance (K063747) on January 12, 2007, and is classified under product code MSH for use in general and plastic surgery settings.