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FDA 510(k)

Henan Yadu Level 4 Surgical Gowns (Reinforced)

K-Number: K252301 · 2026-02-04

ApplicantYadu Medical (Henan) Co., Ltd.
Decision Date2026-02-04
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Henan Yadu Level 4 Surgical Gowns (Reinforced) is a medical device manufactured by Yadu Medical (Henan) Co., Ltd.. It received FDA 510(k) clearance on 2026-02-04 under approval number K252301. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Henan Yadu Level 4 Surgical Gowns (Reinforced)?

Henan Yadu Level 4 Surgical Gowns (Reinforced) is a medical device that received FDA 510(k) clearance on 2026-02-04. It is manufactured by Yadu Medical (Henan) Co., Ltd.. The 510(k) number is K252301.

When was Henan Yadu Level 4 Surgical Gowns (Reinforced) approved by the FDA?

Henan Yadu Level 4 Surgical Gowns (Reinforced) received FDA 510(k) clearance on 2026-02-04, under approval number K252301.

What company makes Henan Yadu Level 4 Surgical Gowns (Reinforced)?

Henan Yadu Level 4 Surgical Gowns (Reinforced) is manufactured by Yadu Medical (Henan) Co., Ltd..

What is the FDA product code for Henan Yadu Level 4 Surgical Gowns (Reinforced)?

The FDA product code for Henan Yadu Level 4 Surgical Gowns (Reinforced) is FYA.

Related Clinical Trials

NCT07607457 Development and Evaluation of the Effectiveness of Patient Gowns for Patients Undergoing Abdominal Surgery NOT_YET_RECRUITING NCT07609888 Photodynamic Therapy as an Adjunct to Non-Surgical Periodontal Therapy in Stage II Periodontitis: A Randomized Split-Mouth Study COMPLETED NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT02747485 Impact of Diffuse Myocardial Fibrosis on the Ventricular Function in Regurgitant Left-Sided Valve Heart Diseases ( The DIFFUsE Study) ACTIVE_NOT_RECRUITING NCT04859725 HyperSpectral Imaging in Low Grade Glioma ACTIVE_NOT_RECRUITING NCT07580664 Long-term Assessment of BDyn Dynamic Stabilization Device in Patients With Lumbar Degenerative Disc Disease NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026)

Other Devices by Yadu Medical (Henan) Co., Ltd.

K250564Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)

Related Devices (Code: FYA)

K162442ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500Gri Medical & Electrical Technology Co., Ltd. K150598Blockade Surgical GownMedline Industries, Inc. K153255Aero Chrome* Breathable Performance Surgical GownHalyard Health, Inc. K172445RoyalGuard Surgical Gown, i600, BreathableGri Medical & Electrical Technology Co., Ltd. K170762Cardinal Health Non-Reinforced Surgical GownCardinal Health200, LLC K162930Aero Chrome* Select Breathable Performance Surgical GownsHalyard Health, Inc.

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.

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