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)

Yadu Medical Face Mask (Level 1)

K-Number: K212330 · 2022-03-14

ApplicantHenan Yadu Industrial Co., Ltd.
Decision Date2022-03-14
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Yadu Medical Face Mask (Level 1) is a medical device manufactured by Henan Yadu Industrial Co., Ltd.. It received FDA 510(k) clearance on 2022-03-14 under approval number K212330. 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 Yadu Medical Face Mask (Level 1)?

Yadu Medical Face Mask (Level 1) is a medical device that received FDA 510(k) clearance on 2022-03-14. It is manufactured by Henan Yadu Industrial Co., Ltd.. The 510(k) number is K212330.

When was Yadu Medical Face Mask (Level 1) approved by the FDA?

Yadu Medical Face Mask (Level 1) received FDA 510(k) clearance on 2022-03-14, under approval number K212330.

What company makes Yadu Medical Face Mask (Level 1)?

Yadu Medical Face Mask (Level 1) is manufactured by Henan Yadu Industrial Co., Ltd..

What is the FDA product code for Yadu Medical Face Mask (Level 1)?

The FDA product code for Yadu Medical Face Mask (Level 1) is FXX.

Related Clinical Trials

NCT04456569 Geniculate Artery Embolization for Osteoarthritis ACTIVE_NOT_RECRUITING NCT03952598 Studying the Biology of IDH-mutant Gliomas Via Longitudinal Observation of 2-hydroxyglutarate (2-HG) Using MR Spectroscopy SUSPENDED NCT06466161 Conical Forearm and Cylindrical Upper Arm Non-Invasive Blood Pressure (NIBP) Measurements in Pregnant Patients RECRUITING NCT07312214 LED Red Light in Modulating Choroidal Microcirculation to Retard Retinal Atrophy in Pathological Myopia RECRUITING NCT07442903 TRICuspid Intervention and Invasive Hemodynamic Monitoring in Heart Failure RECRUITING NCT07556809 Exoskeleton Gait Training in Guillain-Barré Syndrome: Safety, Feasibility, Usability, and Longitudinal Outcomes COMPLETED

Related PubMed Literature

PMID: 41815749 The history of state preemption and medical device regulation: lessons for artificial intelligence oversight. Health affairs scholar (2026) PMID: 41453025 Characterization and Time-delay in Issuing High-risk Recalls of Orthopaedic Devices From 2002 to 2023. The Journal of the American Academy of Orthopaedic Surgeons (2025) PMID: 41428154 Level of Evidence and Strength of Recommendations in US Medical Society Clinical Practice Guidelines, 2019-2023: A Cross-Sectional Analysis. Journal of general internal medicine (2025) PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

Other Devices by Henan Yadu Industrial Co., Ltd.

K220092YADU Surgical Gowns

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.

↑