Surgical Mask

by Sichuan Prius Biotechnology Co., Ltd China 510(k)

510(k) K210908 Product code FXX

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK210908	Date26 Sep 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Withdrawn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) · synced 22 Oct 2026

510(k) Number: K210908
FDA Product Code: FXX
FDA applicant: Sichuan Prius Biotechnology Co., Ltd.

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

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See all devices from Sichuan Prius Biotechnology Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

FDA 510(k) K210908 24 fields · synced 22 Oct 2026