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KC 300 Surgical Mask

by Kimberly-Clark Corp. 510(k)

Active United States

510(k) K131879

Overview

The KC 300 Surgical Mask is a disposable, non-sterile surgical mask classified under product code FXX. Designed as a physical barrier, it reduces the transfer of microorganisms, body fluids, and particulate matter to help prevent infection in clinical settings.

Intended for single-use by healthcare personnel and patients, the mask is supplied in bulk packaging of 40 per dispenser, with 10 dispensers per case. It holds FDA 510(k) clearance (K131879) under a traditional review process, deemed substantially equivalent to previously cleared Kimberly-Clark surgical masks. No sterility or MRI safety information is specified.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK131879 Date20 Dec 2013ClearedStatusActive

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

1 recall · 1 ongoing · FDA

    • Ongoing Z-1059-2023 FDA Class III initiated 3 Jan 2023

    Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the dispenser is incorrectly labeled as face masks with ties instead of ear loops.

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 Kimberly-Clark Corporation

See all devices from Kimberly-Clark Corporation →

Questions

  • What is the KC 300 Surgical Mask designed to protect against in clinical settings?

    The KC 300 Surgical Mask acts as a physical barrier to reduce the transfer of microorganisms, body fluids, and particulate matter. This helps lower the risk of infection for both healthcare personnel and patients during procedures.

  • Is the KC 300 Surgical Mask reusable or intended for single-use, and how is it packaged?

    The KC 300 Surgical Mask is explicitly designed for single-use only. It is supplied in bulk packaging, with 40 masks per dispenser and 10 dispensers per case, making it convenient for healthcare settings.

  • What should I know about the sterility and regulatory clearance of this mask?

    The KC 300 Surgical Mask is not sterile and does not carry any sterility claims. It holds FDA 510(k) clearance (K131879) under a traditional review process, deemed substantially equivalent to previously cleared Kimberly-Clark surgical masks.

  • How is the KC 300 Surgical Mask classified, and what does that mean for its use?

    The mask is classified under FDA product code FXX, which categorizes it as a surgical mask. This classification means it is intended for use in clinical settings where infection control is critical, such as during surgical procedures or patient care.