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Earloop Face Mask

by Shuenn Bao Shing Corp.

510(k) K990719

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 NumberK990719 Date12 Jul 1999ClearedStatusActive

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  • Withdrawn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, 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.

The Earloop Face Mask is a surgical mask designed to provide a physical barrier for the wearer. It is intended to be worn to help prevent the spread of microorganisms and particulate matter.

This device is classified as a Class II medical device under product code FXX. It has received FDA 510(k) clearance under K990719.

Other devices from Shuenn Bao Shing Corp.

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 primary purpose of the Earloop Face Mask?

    The Earloop Face Mask is designed to serve as a physical barrier for the wearer. Its intended use is to help prevent the spread of microorganisms and particulate matter in clinical or surgical environments.

  • What is the regulatory status of this device?

    This device is classified as a Class II medical device under product code FXX. It has received FDA 510(k) clearance under K990719, which indicates it has been found substantially equivalent to legally marketed predicate devices.

  • Who is the manufacturer of this surgical mask?

    The Earloop Face Mask is manufactured by Shuenn Bao Shing Corp., located in Taipei, Taiwan.