Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Disposable Medical Masks

K-Number: K221038 · 2022-09-01

ApplicantHantech Medical Device Co., Ltd.
Decision Date2022-09-01
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Medical Masks is a medical device manufactured by Hantech Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2022-09-01 under approval number K221038. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Medical Masks?

Disposable Medical Masks is a medical device that received FDA 510(k) clearance on 2022-09-01. It is manufactured by Hantech Medical Device Co., Ltd.. The 510(k) number is K221038.

When was Disposable Medical Masks approved by the FDA?

Disposable Medical Masks received FDA 510(k) clearance on 2022-09-01, under approval number K221038.

What company makes Disposable Medical Masks?

Disposable Medical Masks is manufactured by Hantech Medical Device Co., Ltd..

What is the FDA product code for Disposable Medical Masks?

The FDA product code for Disposable Medical Masks is FXX.

Related Clinical Trials

NCT07060131 Observe the Effects of Far Infrared Eye Masks on Acupoints Around the Eyes in Patients With Dry Eye Syndrome COMPLETED NCT07273877 "Real-world Assessment of BP Control in Patients With Hypertension by the Netrod RDN System" - REACH-RDN ENROLLING_BY_INVITATION

Other Devices by Hantech Medical Device Co., Ltd.

K220603Disposable Medical Safety Hypodermic Needle K231363Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) K222739Disposable Insulin Pen Needle K222672Disposable Insulin Syringe

Related Devices (Code: FXX)

K153409Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC K160269Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd. K152197Skypro, SP01 MaskSkypro Medical Supplies Company K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. K152561Communicator Surgical Facemask with Clear WindowPrestige Ameritech , Ltd. K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap ShieldPrestige Ameritech

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑