Copioumed AAMI 3 Surgical Gown— 510(k) K251860
Substantially EquivalentCopioumed International, Inc.
FDA 510(k) clearance K251860 for Copioumed AAMI 3 Surgical Gown, Substantially Equivalent on 2026-02-26. Applicant: Copioumed International, Inc.. Device class: 2.
Summary
Copioumed International's Copioumed AAMI 3 Surgical Gown is filed under product code FYA, surgical gown. The record doesn't describe the gown beyond its name and that code name.
Class II, 21 CFR 878.4040. The General Hospital review panel handled it as a Traditional 510(k), though the record lists General, Plastic Surgery as the classification panel.
Copioumed International filed from Taipei City, Taiwan. FDA found it substantially equivalent 254 calendar days after receipt (June 17, 2025 to February 26, 2026).
Clearance details
- Applicant
- Copioumed International, Inc.
- 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
- Taipei City, TW
Recent devices under product code FYA
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- K252575 — Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
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More clearances from Copioumed International, Inc.
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