Medical Face Mask

by Haian Medigauze Co., Ltd. 510(k)

Active United States

510(k) K212471

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK212471	Date4 Nov 2021Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k)

510(k) Number: K212471
FDA Product Code: FXX

Device Class: Class II
Regulation: 21 CFR Part 878.4040
Advisory Committee: General, Plastic Surgery
FDA Decision: SESE Substantially Equivalent

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