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FDA 510(k)

BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)

K-Number: K260725 · 2026-05-12

ApplicantHindernis DE Mexico, S.A.P.I. DE C.V.
Decision Date2026-05-12
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) is the device name listed in this FDA 510(k) record. The listed applicant is Hindernis DE Mexico, S.A.P.I. DE C.V.. It received FDA 510(k) clearance on 2026-05-12 under 510(k) number K260725. 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 BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)?

BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) is a medical device that received FDA 510(k) clearance on 2026-05-12. The listed applicant is Hindernis DE Mexico, S.A.P.I. DE C.V.. The 510(k) number is K260725.

When did BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) receive FDA 510(k) clearance?

BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) received FDA 510(k) clearance on 2026-05-12, under 510(k) number K260725.

Who is the listed applicant for BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)?

The FDA 510(k) record lists Hindernis DE Mexico, S.A.P.I. DE C.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)?

The FDA product code for BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) is FYA.

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)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

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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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