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BASE4 Disposable Medical Mask

by Base4 Group, Inc.

510(k) K202069

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 · Abbreviated NumberK202069 Date1 Dec 2020ClearedStatusActive

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  • Withdrawn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, 19 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 BASE4 Disposable Medical Mask is a surgical mask designed to provide barrier protection against droplets and splashes, as defined under the FDA’s product code FXX. It is classified as a disposable medical device intended for single-use in healthcare settings to reduce the risk of contamination from the user’s respiratory secretions and airborne particles.

This mask is supplied in a sterile, non-reusable form and is intended for use in general hospital environments. It complies with FDA 510(k) clearance (K202069) under the Abbreviated 510(k) pathway, with no third-party review required. Sizes and packaging details are not specified in the regulatory data, but it is intended for one-time use per the disposable classification.

Questions

AI-generated answers, 19 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 BASE4 Disposable Medical Mask primarily designed to protect against in healthcare settings?

    The BASE4 Disposable Medical Mask is designed to provide barrier protection against droplets and splashes, helping to reduce contamination risks from the user’s respiratory secretions and airborne particles in healthcare environments.

  • Is the BASE4 Disposable Medical Mask reusable, or is it meant for single-use only?

    The mask is explicitly classified as a disposable medical device, meaning it is intended for single-use only. Reuse is not recommended or supported by its design.

  • How is the BASE4 Disposable Medical Mask supplied, and is it sterile?

    The mask is supplied in a sterile form, ensuring it meets healthcare standards for cleanliness before use. This sterility is critical for reducing infection risks in clinical settings.

  • What regulatory pathway was used for FDA clearance of the BASE4 Disposable Medical Mask?

    The mask was cleared through the FDA’s Abbreviated 510(k) pathway (K202069), which does not require third-party review, and was determined to be substantially equivalent to a predicate device.

  • Are there specific size options available for the BASE4 Disposable Medical Mask?

    The regulatory data does not specify exact sizes or packaging details for the BASE4 Disposable Medical Mask, so potential buyers should confirm available options directly with the manufacturer.