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Medical Surgical Masks-Non Sterile

by Shandong T&F Nonwoven Co., Ltd.

510(k) K202594

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 NumberK202594 Date6 Jan 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  • Withdrawn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, 21 Sep 2026

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

Medical Surgical Masks-Non Sterile is a surgical mask classified as Mask, Surgical (product code FXX), Class II - Special Controls. It is intended for use in infection control practices to reduce the potential exposure to blood and body fluids.

This is a single-use, disposable device provided non-sterile. It received FDA 510(k) clearance on January 6, 2021 under K-number K202594, submitted by Shandong T&F Nonwoven Co., Ltd. of Qingdao, China.

Questions

AI-generated answers, 21 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 Medical Surgical Masks-Non Sterile intended for?

    It is intended for use in infection control practices to reduce the potential exposure to blood and body fluids, as stated in its description and FDA 510(k) submission.

  • Is the Medical Surgical Masks-Non Sterile sterile or non-sterile, and is it reusable?

    The device is provided non-sterile and is designated as single-use and disposable, meaning it is not intended for reuse after initial use.

  • What regulatory clearance does the Medical Surgical Masks-Non Sterile have and when was it granted?

    It received FDA 510(k) clearance on January 6, 2021, under K-number K202594, confirming it is substantially equivalent to a legally marketed predicate device.