Disposable Medical Masks

by Hantech Medical Device Co., Ltd. China 510(k)

510(k) K221038 Product code FXX

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK221038	Date1 Sep 2022Cleared	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Withdrawn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: K221038
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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Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)

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Disposable Medical Safety Hypodermic Needle

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Disposable Insulin Pen Needle

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See all devices from Hantech Medical Device Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

FDA 510(k) K221038 24 fields · synced 22 Oct 2026