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Technoweb Surgical Mask

by Yts Global, Inc.

510(k) K172500

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 NumberK172500 Date1 Mar 2018ClearedStatusActive

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  • Withdrawn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 Technoweb Surgical Mask is a disposable, fluid-resistant barrier device classified as a surgical mask under FDA product code FXX. Designed to protect healthcare personnel and patients from airborne contaminants and splashes, it conforms to standards for surgical procedures requiring minimal particulate and liquid penetration.

Supplied in sterile packaging for single-use, the mask is intended for use in general hospital settings. It adheres to FDA 510(k) clearance (K172500) under the Traditional review pathway, with no third-party certification noted. Sizes and configurations are not specified in the regulatory data, but compliance with fluid resistance and filtration standards is implied by its classification. Storage requires protection from moisture and physical damage to maintain sterility.

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 Technoweb Surgical Mask designed to protect against?

    The Technoweb Surgical Mask is a disposable, fluid-resistant barrier device intended to protect healthcare personnel and patients from airborne contaminants and liquid splashes during surgical procedures. Its classification under FDA product code FXX ensures it meets standards for minimal particulate and liquid penetration, making it suitable for environments where contamination control is critical.

  • Is the Technoweb Surgical Mask single-use or reusable?

    The Technoweb Surgical Mask is explicitly supplied in sterile packaging, indicating it is designed for single-use only. Reuse could compromise sterility and fluid resistance, potentially exposing users to contamination risks. Always adhere to manufacturer guidelines to maintain safety and compliance.

  • How should the Technoweb Surgical Mask be stored to preserve sterility?

    To maintain sterility, store the Technoweb Surgical Mask in its original packaging, away from moisture, direct sunlight, and physical damage. Exposure to humidity or contaminants may compromise the mask’s barrier properties. Ensure the packaging remains intact until immediate pre-use to prevent microbial or particulate contamination.

  • Does the Technoweb Surgical Mask require third-party certification?

    No third-party certification is noted for the Technoweb Surgical Mask in the available regulatory data. Its compliance is established through FDA 510(k) clearance (K172500) under the Traditional review pathway, which evaluates substantial equivalence to predicate devices without mandatory third-party involvement. Always verify current regulatory status via official databases.

  • What are the key differences between this mask and standard surgical masks?

    The Technoweb Surgical Mask is distinguished by its FDA-cleared fluid resistance, which implies enhanced protection against liquid penetration compared to basic surgical masks. While standard masks may offer particulate filtration, this device’s classification under product code FXX suggests it meets stricter standards for surgical environments requiring barrier integrity. Size or configuration specifics are not detailed, but its sterility and single-use design align with high-risk medical settings.