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FDA 510(k)

Copioumed AAMI 3 Surgical Gown

K-Number: K251860 · 2026-02-26

ApplicantCopioumed International, Inc.
Decision Date2026-02-26
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Copioumed AAMI 3 Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is Copioumed International, Inc.. It received FDA 510(k) clearance on 2026-02-26 under 510(k) number K251860. 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 Copioumed AAMI 3 Surgical Gown?

Copioumed AAMI 3 Surgical Gown is a medical device that received FDA 510(k) clearance on 2026-02-26. The listed applicant is Copioumed International, Inc.. The 510(k) number is K251860.

When did Copioumed AAMI 3 Surgical Gown receive FDA 510(k) clearance?

Copioumed AAMI 3 Surgical Gown received FDA 510(k) clearance on 2026-02-26, under 510(k) number K251860.

Who is the listed applicant for Copioumed AAMI 3 Surgical Gown?

The FDA 510(k) record lists Copioumed International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Copioumed AAMI 3 Surgical Gown?

The FDA product code for Copioumed AAMI 3 Surgical Gown is FYA.

Other records listing Copioumed International, Inc. 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.

K230135Copioumed Chemotherapy Isolation Gown

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.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.

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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