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MIPLNI YK-244 Disposable Surgical Mask

by Hunan Yuankang Biological Technology Co., Ltd.

510(k) K210487

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 NumberK210487 Date16 Mar 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  • Withdrawn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, 6 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 MIPLNI YK-244 Disposable Surgical Mask is a surgical mask device classified under product code FXX and regulation 878.4040. It is substantially equivalent to a legally marketed predicate device as determined by FDA 510(k) clearance.

The device is supplied as a disposable, non-sterile surgical mask intended for use in general and plastic surgery settings. It is not indicated as MRI safe or reusable, and no specific sizes, storage conditions, or additional authorisations beyond the FDA 510(k) clearance are provided in the data.

Questions

AI-generated answers, 6 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 clinical settings is the MIPLNI YK-244 intended for?

    It is supplied for use in general surgery and plastic surgery environments. The device description specifies these specialties, indicating it meets the performance requirements for barrier protection in those operative contexts.

  • Is the MIPLNI YK-244 mask sterile or reusable?

    The mask is provided as a non‑sterile, single‑use product. The data explicitly state it is disposable and not indicated as reusable, so each mask is intended for one procedure and then discarded.

  • How is the MIPLNI YK-244 marketed and regulated?

    It received traditional FDA 510(k) clearance, meaning it was found substantially equivalent to a legally marketed predicate device. The clearance is recorded under product code FXX and decision code SESE.

  • Are there any size options or special storage requirements for this mask?

    The provided information does not list specific sizes or storage conditions. Therefore, the mask is supplied without size differentiation and can be stored under typical room‑temperature conditions unless otherwise indicated by the manufacturer.