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FDA 510(k)

Surgical Gown

K-Number: K213703 · 2022-03-04

ApplicantWujiang Tutaike Textiles & Finishing Co., Ltd.
Decision Date2022-03-04
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Gown is a medical device manufactured by Wujiang Tutaike Textiles & Finishing Co., Ltd.. It received FDA 510(k) clearance on 2022-03-04 under approval number K213703. 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 2022-03-04. It is manufactured by Wujiang Tutaike Textiles & Finishing Co., Ltd.. The 510(k) number is K213703.

When was Surgical Gown approved by the FDA?

Surgical Gown received FDA 510(k) clearance on 2022-03-04, under approval number K213703.

What company makes Surgical Gown?

Surgical Gown is manufactured by Wujiang Tutaike Textiles & Finishing Co., Ltd..

What is the FDA product code for Surgical Gown?

The FDA product code for Surgical Gown is FYA.

Other Devices by Wujiang Tutaike Textiles & Finishing Co., Ltd.

K211077Surgical 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.

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