BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)— 510(k) K260725
Substantially EquivalentHindernis DE Mexico, S.A.P.I. DE C.V.
FDA 510(k) clearance K260725 for BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10), Substantially Equivalent on 2026-05-12. Applicant: Hindernis DE Mexico, S.A.P.I. DE C.V.. Device class: 2.
Summary
Hindernis de Mexico's BAÜMER Surgical Gowns are listed in four models (COP01, COP04, COP05, COP10) under FYA, surgical gowns.
Class II, 21 CFR 878.4040. The General Hospital review panel handled it as a Traditional 510(k), though the record lists General and Plastic Surgery as the classification panel.
Hindernis filed from Naucalpan De Juarez, Mexico. Review took 68 calendar days (March 5 to May 12, 2026).
Clearance details
- Applicant
- Hindernis DE Mexico, S.A.P.I. DE C.V.
- Product code
- Product code FYA
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Naucalpan De Juarez, MX
Recent devices under product code FYA
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- K261028 — Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)
- K261949 — NYES Tuff Cuff L3 Disposable Gowns
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- K253243 — Cardinal Health Poly Reinforced Surgical Gown
Data sourced from openFDA. This site is unofficial and independent of the FDA.