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Intec Extended Eye Shield With Mask

by Intec Industries, Inc. 510(k)

Active United States

510(k) K946343

Overview

The Intec Extended Eye Shield With Mask is a disposable eye and face shield designed for surgical use. It provides protection for the eyes during medical procedures in general and plastic surgery settings.

This device is supplied as a single-use item and is regulated under FDA 510(k) clearance K946343 with product code FXX. It is classified as a Class II medical device and was determined to be substantially equivalent to predicate devices.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK946343 Date22 Mar 1995ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

Other devices from Intec Industries, Inc.

Questions

  • What is the Intec Extended Eye Shield With Mask used for?

    The Intec Extended Eye Shield With Mask is a disposable eye and face shield designed for surgical use, providing protection for the eyes during medical procedures in general and plastic surgery settings.

  • Is the Intec Extended Eye Shield With Mask a single-use or reusable device?

    The Intec Extended Eye Shield With Mask is supplied as a single-use item, meaning it should be discarded after one procedure to ensure proper hygiene and effectiveness.

  • What is the regulatory status of the Intec Extended Eye Shield With Mask?

    The device is regulated under FDA 510(k) clearance K946343 with product code FXX. It is classified as a Class II medical device and was determined to be substantially equivalent to predicate devices.

  • How is the Intec Extended Eye Shield With Mask supplied?

    The Intec Extended Eye Shield With Mask is supplied as a disposable item, ready for immediate use in surgical settings without requiring additional preparation or sterilization.