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FDA 510(k)

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

K-Number: K250564 · 2025-12-03

ApplicantYadu Medical (Henan) Co., Ltd.
Decision Date2025-12-03
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) is a medical device manufactured by Yadu Medical (Henan) Co., Ltd.. It received FDA 510(k) clearance on 2025-12-03 under approval number K250564. 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 Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)?

Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) is a medical device that received FDA 510(k) clearance on 2025-12-03. It is manufactured by Yadu Medical (Henan) Co., Ltd.. The 510(k) number is K250564.

When was Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) approved by the FDA?

Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) received FDA 510(k) clearance on 2025-12-03, under approval number K250564.

What company makes Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)?

Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) is manufactured by Yadu Medical (Henan) Co., Ltd..

What is the FDA product code for Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)?

The FDA product code for Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) is FYA.

Related Clinical Trials

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 NCT07524712 Effects of Energy Versus Mechanical Surgical Devices on Postoperative Cough 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.

K252301Henan Yadu Level 4 Surgical Gowns (Reinforced)

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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