FDA 510(k)

Surgical Gown

K-Number: K211809 · 2021-10-18

ApplicantWuhan Dymex Healthcare Co., Ltd.

Decision Date2021-10-18

Product CodeFYA

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Surgical Gown is a medical device manufactured by Wuhan Dymex Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2021-10-18 under approval number K211809. 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 Surgical Gown?

Surgical Gown is a medical device that received FDA 510(k) clearance on 2021-10-18. It is manufactured by Wuhan Dymex Healthcare Co., Ltd.. The 510(k) number is K211809.

When was Surgical Gown approved by the FDA?

Surgical Gown received FDA 510(k) clearance on 2021-10-18, under approval number K211809.

What company makes Surgical Gown?

Surgical Gown is manufactured by Wuhan Dymex Healthcare Co., Ltd..

What is the FDA product code for Surgical Gown?

The FDA product code for Surgical Gown is FYA.

Other Devices by Wuhan Dymex Healthcare Co., Ltd.

K182515Surgical Face Mask K210433Surgical Face Mask (Ear loops and Tie-on) K220528Surgical Isolation Cover 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

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