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FDA 510(k)

Cardinal Health™ Poly Reinforced Surgical Gown

K-Number: K253243 · 2026-04-28

ApplicantCardinal Health 200, LLC
Decision Date2026-04-28
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Cardinal Health™ Poly Reinforced Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health 200, LLC. It received FDA 510(k) clearance on 2026-04-28 under 510(k) number K253243. 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 Cardinal Health™ Poly Reinforced Surgical Gown?

Cardinal Health™ Poly Reinforced Surgical Gown is a medical device that received FDA 510(k) clearance on 2026-04-28. The listed applicant is Cardinal Health 200, LLC. The 510(k) number is K253243.

When did Cardinal Health™ Poly Reinforced Surgical Gown receive FDA 510(k) clearance?

Cardinal Health™ Poly Reinforced Surgical Gown received FDA 510(k) clearance on 2026-04-28, under 510(k) number K253243.

Who is the listed applicant for Cardinal Health™ Poly Reinforced Surgical Gown?

The FDA 510(k) record lists Cardinal Health 200, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cardinal Health™ Poly Reinforced Surgical Gown?

The FDA product code for Cardinal Health™ Poly Reinforced Surgical Gown is FYA.

Other records listing Cardinal Health 200, LLC 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.

K151778Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating

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.

K261028Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd.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.K253003Non-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

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

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