FDA 510(k)

Copioumed AAMI 3 Surgical Gown

K-Number: K251860 · 2026-02-26

Decision Date2026-02-26

Product CodeFYA

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Copioumed AAMI 3 Surgical Gown is a medical device manufactured by Copioumed International, Inc.. It received FDA 510(k) clearance on 2026-02-26 under approval 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. It is manufactured by Copioumed International, Inc.. The 510(k) number is K251860.

When was Copioumed AAMI 3 Surgical Gown approved by the FDA?

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

What company makes Copioumed AAMI 3 Surgical Gown?

Copioumed AAMI 3 Surgical Gown is manufactured by Copioumed International, Inc..

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 Devices by Copioumed International, Inc.

K230135Copioumed Chemotherapy Isolation Gown

Related Devices (Code: FYA)

K162442ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500Gri Medical & Electrical Technology Co., Ltd. K150598Blockade Surgical GownMedline Industries, Inc. K153255Aero Chrome* Breathable Performance Surgical GownHalyard Health, Inc. K172445RoyalGuard Surgical Gown, i600, BreathableGri Medical & Electrical Technology Co., Ltd. K170762Cardinal Health Non-Reinforced Surgical GownCardinal Health200, LLC K162930Aero Chrome* Select Breathable Performance Surgical GownsHalyard Health, Inc.

Official Source

View on FDA Database →

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