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Secure Wear USA Surgical Face Mask

by Secured Ortho Manufacturing of America, LLC

510(k) K203101

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 NumberK203101 Date31 Mar 2021ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 1 Oct 2026

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

The Secure Wear USA Surgical Face Mask is a single-use, non-sterile, disposable surgical apparel device designed to function as a physical barrier. It protects both patients and healthcare professionals from the transfer of microorganisms, body fluids, and particulate material.

This device is supplied by Secured Ortho Manufacturing of America, LLC and is intended for use in general and plastic surgery settings. It is a single-use, non-sterile item that is not intended for reuse. The device is manufactured in the USA and is authorized under FDA 510(k) clearance K203101.

Questions

AI-generated answers, 1 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 purpose of the Secure Wear USA Surgical Face Mask?

    The Secure Wear USA Surgical Face Mask is designed to function as a physical barrier that protects both patients and healthcare professionals from the transfer of microorganisms, body fluids, and particulate material in general and plastic surgery settings.

  • Is the Secure Wear USA Surgical Face Mask sterile or reusable?

    The Secure Wear USA Surgical Face Mask is a single-use, non-sterile item that is not intended for reuse. It should be discarded after each use to maintain its protective function and prevent cross-contamination.

  • What are the regulatory approvals for this surgical face mask?

    The Secure Wear USA Surgical Face Mask is manufactured in the USA and is authorized under FDA 510(k) clearance K203101, which means it has been determined to be substantially equivalent to other legally marketed devices.

  • How is the Secure Wear USA Surgical Face Mask supplied?

    The device is supplied by Secured Ortho Manufacturing of America, LLC, located at 28 W. Jefryn Blvd. Suite C, Deer Park, NY 11729. It is packaged as a single-use, disposable item ready for immediate use in clinical settings.