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FDA 510(k)

Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)

K-Number: K261028 · 2026-08-07

ApplicantYadu Medical (Henan) Co., Ltd.
Decision Date2026-08-07
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) is the device name listed in this FDA 510(k) record. The listed applicant is Yadu Medical (Henan) Co., Ltd.. It received FDA 510(k) clearance on 2026-08-07 under 510(k) number K261028. 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 Level2 (S, M, L, XL, XXL, XXXL)?

Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) is a medical device that received FDA 510(k) clearance on 2026-08-07. The listed applicant is Yadu Medical (Henan) Co., Ltd.. The 510(k) number is K261028.

When did Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) receive FDA 510(k) clearance?

Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) received FDA 510(k) clearance on 2026-08-07, under 510(k) number K261028.

Who is the listed applicant for Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)?

The FDA 510(k) record lists Yadu Medical (Henan) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)?

The FDA product code for Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) is FYA.

Other records listing Yadu Medical (Henan) Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252301Henan Yadu Level 4 Surgical Gowns (Reinforced)K250564Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)

Related Devices (Code: FYA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261949NYES Tuff Cuff L3 Disposable GownsNew York Embroidery StudioK252575Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)New York Embroidery Studio (NYES)K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V.K253243Cardinal Health™ Poly Reinforced Surgical GownCardinal Health 200, LLCK253003Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)Hubei Xinxin Non-Woven Co., Ltd.K251860Copioumed AAMI 3 Surgical GownCopioumed International, 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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